ORTHOFIX: DEFECTIVE M6 ARTIFICIAL DISC, DESIGN FLAWS: CRIMINAL AND UNHETICAL BEHAVIOR FROM MEDICAL IMPLANT MANUFACTURER ORTHOFIX

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Press Package Available & Patients Contact at m6discfailures@gmail.com

Update: Orthofix tried to contact directly patients, bypassing their Attorney

It is obvious that Orthofix Executives never respect the law. After being sued so many times Orthofix should realize that certain lines should never be crossed. Some patients suing Orthofix have been directly contacted by Orthofix during the last few weeks. No lawyer was involved on the patient’s side. As Orthofix has a huge councel the company should know the act of reaching out to patients involved in a lawsuit by phone is illegal when these patients already hired a lawyer to sue the Medical Device Company based in Texas.

So far Orthofix has been doing nothing in court to take responsibility and help patients who have been physically damaged.

Multiple videos of Orthofix contacting patients have been shared with the advocacy group. Some patients feel scared and threatened by Orthofix’s Management aggressive behavior. These videos will be sent to the FDA because this situation is unacceptable ! Orthofix’s behavior was intended to intimidate patients during direct negociation.

The Chief Legal and Development Officer, Ms Kimberley Elting went as far as telling a patient she felt insulted when the same patient asked for a larger settlement. The patient is still in his thirties, cannot work and Orthofix offered a ridiculous low settlement. Ms Elting replied with a very “Inappropriate” and “Salty” email to dishearten the vulnerable and unexperienced patient.

Dream advertisement for the poorly designed M6 Artificial Disc:

It is clear that this young surfer, Koa Rothman doesn’t know what he is getting into. The young man had surgery in June 2022 so this is very new to him and cannot really give a fair testimonial. He is also feeling extremely well right after surgery when all patients require a year to heal so this is very questionable.

We have seen the M6-C failed from a year to an extensive period of 7 years after implantation.

This commercial is extremely controversial when we know the Sr. Director of Quality Assurance at Orthofix, Peter kollings said to a patient that :

The M6 Disc is far from being perfect

Recording of this conversation with Peter Kollings and VP, Joe Ross has been shared. This is seriously unethical and criminal to offer implants having a design defect and put thousands of lives at risk. When the Sr. Director of Quality Assurance tells you that the M6 Disc is far from being perfect we are seriously wondering what it means ! This Quality Director recently left Orthofix.

We can see on this image that the M6-C disc is far from being perfect.

Orthofix is trying to cover up their failures to monetize the M6 Disc

This is just to respond to Orthofix and their extremely gentle Product Liability Lawyer Ms Ginger Pigott who reached out to patients who had issues with the M6 Disc. Ms Pigott said Orthofix does not agree with the information posted on this blog and that we had no scientific evidence. She said she would reach out to us again but never did.

Ms Pigott should know we posted 60 pages full of scientific evidence on this blog to show that the M6 Disc Design is a total failure ! We understand that Orthofix spent $200 Million to get an FDA clearance for the M6 and really wants to get its investment back so ruining the patients lives to monetize the M6 Disc is the only way just like when Orthofix sold defective spine a fusion screw banned worldwide to Brazilian surgeons and arranged for this screw to be the only one sold in Brazil before Brazilian patients started to develop a bone reaction to the material.

Ms Pigott said during the meeting we had on Zoom that:

Orthofix will never compensate all the victims who experienced M6 Disc failures because if they would do it Orthofix would get bankrupt and would not have the fund to innovate in the future” so we understood that Orthofix test their medical devices on patients as no Human Studies have been found so far (the only studies found were done on rabbits and goat for the M6) and then leave the patients broken financially, psychologically and physically. Orthofix offered 6000 euros as settlement to a woman who will never work again. That’s the kind of care Orthofix offers to its M6 recipients.

The Attorney Ginger Pigott has a very nice video on Youtube and talks about a correlation between Valuation and Reputation in the Medical Device Industry and that’s exactly what she does for Orthofix. (Medical device industry trends affecting innovation – YouTube)

Ms Pigott is part of Mansfield Rule, an organization working to increase and sustain a diverse and inclusive workforce in law firms. Ms Pigott promotes women to access high level jobs but does not mind defending Orthofix, a company involved in sexual harassment of a young female employee. Ms Pigott and her Law Firm Greenberg Traurig don’t seem to show any ethic in this case !

Welding issues and Fatigue fracture on the M6-C

Here is probably the kind of issues Sr Director of Quality Assurance Peter Kollings was referring to when he said “The M6 is far from being perfect

We talked to one of the best expert in Biomechanics and he told us the M6 Artificial Disc in most cases changes the load repartition on the spine as the nucleus of the M6 is made just like a rubber ball. Many adverse events happened from an endplate crack due to a welding pulse creating a fatigue fracture, bent endplates and complete failure of the core seen below.

UPDATE: THIS TYPE OF LEARDERSHIP MAKES YOU WONDER IF ORTHOFIX MANAGEMENT TAKES CONFLICT OF INTEREST SERIOUSLY ?

After Orthofix was found guilty of sexual abuse, fraud, paying surgeons for pushing the implantation of their devices and now this new investigation makes M6 Disc recipients really questionning if Orthofix illegally paid surgeons in Europe for implanting the defective M6 Artificial Disc. Orthofix leadership does not seem to mind breaking the law to make the company as profitable as possible !

A 26 year old German Woman almost died following an implantation of the M6 Disc by “Spine surgeon” Jan Spiller from Stenum (Enande) Clinic in Germany.

The M6 Artificial Disc has an obvious Design Defect.

Extensive scientific evidence showing many design problems found on the M6-C reported by the Federal Institute for Materials Research and Testing (BAM) located in Germany !

Update: “Doctor” Ritter Lang and Orthofix accused patients from the Advocacy Group of having no ground based scientific evidence so here are 60 pages showing some science behind the M6 Disc Failure:

https://www.scribd.com/document/573728944/M6-Artificial-Disc-Failure-Report-1st-part

https://www.scribd.com/document/573729082/M6-Artificial-Disc-Failure-Report-Second-part

https://www.scribd.com/document/573729157/M6-Artificial-Disc-Failure-Report-3rd-part

After all this, it is hard to believe that Mr Ritter-Lang and Orthofix are denying there are some issues with the M6 Disc design.

UPDATE: After selling defective artificial discs Orthofix is involved in sexual harassment

BACKGROUND

On June 14, 2019, Plaintiff filed her Complaint, alleging discrimination, hostile work environment, and retaliation claims under Title VII against Defendant Options Medical and Defendant Orthofix, Inc. (“Orthofix”) (Dkt. #1 at p. 7). From approximately November 2016 until September 28, 2017, Plaintiff was employed as a Junior Associate Territory Manager by Defendant Options Medical in Gainesville, Florida, where she traveled to doctors’ offices in Florida to obtain paperwork authorizing the use of Defendant Orthofix’s devices (Dkt. #1 at pp. 1, 4).

Plaintiff’s Title VII claims center around two, discrete sets of events—one occurring entirely in Florida, the other occurring entirely in Texas. First, Plaintiff claims that while working as a Territory Manager for Defendant Options Medical in Florida, she was subjected to severe and  pervasive sexual harassment by a Florida neurosurgeon who was one of Defendant Options Medical’s largest accounts (Dkt. #1 at p. 4). Plaintiff alleges she reported this harassment and that this harassment was witnessed by Defendant Options Medical’s management, but Options Medical did not investigate and took no remedial measures (Dkt. #1 at p. 5). Plaintiff also alleges that Defendant Options Medical encouraged her endure the Florida neurosurgeon’s harassment, retaliated against her for reporting it, and subjected her to a constructive discharge (Dkt. #1 at pp. 5-6).

Plaintiff alleges that the second set of events occurred around August 7, 2017, after she was sent to Texas for a product-training event by Defendant Options Medical (Dkt. #1 at p. 6; Dkt. #11, Exhibit A ¶ 15). The training was at Orthofix’s headquarters in Lewisville, Texas (Dkt. #1 at p. 6).

Plaintiff claims she discussed the Florida neurosurgeon’s harassment with Orthofix’s president at the training, but Orthofix did nothing to investigate (Dkt. #1 at p. 6).

Plaintiff then alleges that the next night, Orthofix’s president invited Plaintiff to go to a night club with him, where he asked one of Plaintiff’s colleagues to inform Plaintiff that he would like to date her (Dkt. #1 ¶ 26).

No one at Defendant Options Medical was informed of Plaintiff’s alleged interactions with Orthofix’s president (Dkt. #11, Exhibit A ¶¶ 14-15).

Plaintiff claims she was “Defendants’ employee” at all relevant times, but there are no facts in her complaint indicating that she was ever employed by Defendant Orthofix (Dkt. #1 at p. 3). Around February 2019, nearly two years after Plaintiff stopped working for Defendant Options Medical, Defendant Orthofix acquired Options Medical as the result of an asset-purchase agreement (Dkt. #1 at p. 3; Dkt. #11, Exhibit A ¶ 17). https://casetext.com/case/boston-v-orthofix-med-inc

Dr Ritter-Lang, German Surgeon who implanted thousands of M6 discs insults Patients ruined by the M6 disc

Dr Ritter-Lang contacted our Advocacy Group insulting Patients of being “anonymous cowards”:

https://i.postimg.cc/SsLQpWLg/temp-6.jpg

Here is a public statement to respond to Dr Ritter-Lang and to Stenum Clinic:

Dr Ritter-Lang seems to have already forgotten how many lives he ruined and how many patients he ignored after having life threatening issues with the M6 disc. We interviewed a 28 year old woman for “Guinea Pig Documentary” who was so close to need a leg amputation right after a revision surgery due to a failure of the M6-L implanted at Stenum. This is far from being the only case with very young patients. Dr Ritter-Lang never sees any problem with failed M6 discs when other surgeons have to fix his mistakes.

Dr Ritter-Lang calling out his own patients who are fighting for their rights is not very appropriate.

There is no propaganda on this website. Patients are only sharing their true experiences. Dr Ritter-Lang has a problem with the way Patients are currently making decisions on their surgeries with a more critical thinking. Does the German surgeon also want Patients to hand him a huge amount of money without asking questions when so many M6 discs already failed ?

Mr Ritter-Lang is currently getting sued in Germany. He is responsible for so many failures of the M6 disc and keeps using it. We never accused Mr Ritter-Lang of corruption but we are clearly wondering why he is still using the M6 disc knowing it has some design defects when Orthofix was prosecuted in the US and in Brazil for paying illegally surgeons.

Patients from the Advocacy Group are not hiding and will be more than happy to interview Doctor Ritter-Lang for the “GUINEA PIG” Documentary. The surgeon is free to contact us.

Mr Ritter-Lang states the “unscientific claims” on this website and he is right. Pictures and stories coming from patients talk for themselves and are worth way more than data and pseudo-testing done internally at Orthofix. The Stenum surgeon dismisses how patients feel when they have a device failure.

We are clearly wondering if Mr Ritter-Lang lacks some scientific/critical thinking to question his work and why does he keeps implanting a device that failed so many times ? Why doesn’t he question if the M6 disc is a good alternative to other technics and other similar implants already present on the market ? So how can Mr Ritter-Lang call himself a doctor when he is not concerned of his own patients well being ?

Mr Ritter-Lang should know that no human-factor study for the M6-disc is known to the public. Mr Ritter-Lang should know that another surgeon was prosecuted weeks ago and a documentary about the M6 failure was broadcasted on National TV in Germany a month ago. We will publish this documentary with the translation very soon.

A German surgeon was sued in Germany for an M6 failure:

Update: Many lawyers have been dropping cases against Orthofix and surgeons are not sanctioned for implanting these defective M6 discs.

All cases against Orthofix manufacturer have been dismissed in court. It seems that so far Orthofix has been too big to fail but patients have some serious allegations in Germany and in the US against Orthofix top management. Numerous patients have been contacted by Orthofix being offered a very small settlement with a contract that often asks patients to hide & lie about the reason of the failure. Orthofix’s Chief Legal & Development Officer, Kimberley Elting felt insulted by a young patient who asked nicely for a larger settlement when the amount offered by the manufacturer was only a few thousand dollars.

Ms Elting recommended the bedridden patient to choose a very conservative surgery that would leave him crippled for the rest of his life. It looks like Orthofix knows extremely well how to navigate the legal system and take advantage of the fact that patients are spread in different parts of the world.

The Orthofix’s Chief Legal & Development Officer, Kimberley Elting has been reaching out to a few desperate and disabled patients to quiet them with very small money. A woman who is on disability was offered a settlement as low as €6000 for the rest of her life when Kimberley Elting estimated Net Worth was at least  $3.37 Million dollars as of 18 November 2021. Ms. Elting owns over 1,000 units of Orthofix Medical Inc stock worth over $1,555,732 and over the last 6 years she sold OFIX stock worth. In addition, she makes $1,809,760 as Chief Legal and Administrative Officer at Orthofix Medical Inc and other Executives make even more on the back of vulnerable patients. https://de.wallmine.com/people/17958/kimberley-a-elting

Mrs Elting and other Executives seem to defend their assets extremely well !

Orthofix’s Vice President & Quality Director admits: “The M6 is far from being perfect”

Vice president & Quality Director called one  patients and admitted on the phone that “The M6 disc is far from being perfect”. Recording, videos and contracts have been leaked.

Orthofix advertises the M6 disc as being the equivalent of a natural spinal disc when this device has shown to fail in hundreds of patients from all over the world  ! The advertising is clearly showing a close to “perfect” device or at least an artificial spinal disc that will outlast the patient.

We conclude that the reality is opposite from what is advertised with Orthofix and their clinical  representatives not providing all the facts and adverse events but only emphasizing “false efficacy”.

Videos, recording and contracts will be published very soon !

Midterm osteolysis‑induced aseptic failure of the M6‑C™ cervical total disc replacement secondary to polyethylene wear debris

It became clear that the M6-C and M6-L have serious design issues.

Here is an official study published:

https://link.springer.com/article/10.1007/s00586-021-07094-7

A DOCUMENTARY IS IN THE WORKS: GUINEA PIG. NO FIX FROM ORTHO.FIX

Patients keep fighting ! This is for all the patients suffering from a failure of the M6 disc.

We always need more testimonials for this documentary. If you had a failure of the M6 disc please contact us at: m6discfailures@gmail.com

Here is a very undone Trailer Sample Test. Lots of B roll have nothing to do in it but we just wanted to see what we could get. We filmed and keep filming a lot more patients:

ORTHOFIX REFUSES TO TAKE REPONSIBILITY AND PATIENTS HAVE TO GO THROUGH SO MUCH TO REMOVE THESE FAULTY M6 DISCS. THE FEW SURGEONS WHO ARE WILLING TO HELP NEED CLOSE TO 10 HOURS TO REMOVE THE M6 DISC. THIS SURGERY IS CLEARLY LIFE THREATENING AND ORTHOFIX IS PUTTING MORE & MORE PATIENTS AT RISK BY IMPLANTING MORE M6 DISCS.

Most Patients having issues with the M6 are left disabled, unable to work when Orthofix has a $600 Million Market Cap and keeps making money with the defective M6.

WE KEEP SEING MORE AND MORE FAILURES OF THE M6 DISC AND ORTHOFIX KEEPS TRAINING SURGEONS HOW TO IMPLANT THIS DANGEROUS DEVICE !

A complete failure after just a few days of implantation !

M6 disc completely failed.
M6 disc completely failed.

Below this M6 disc was removed a few weeks ago and the patient had to get a 360 Fusion:

M6 disc removed converted into a 360 fusion
Orthofix Campaign, M6 Artificial disc failure

More adverse events have been reported:

More patients have been coming foward to denounce their catastrophic outcome after getting the M6 Disc implanted.

M6 Disc
M6 Disc: We can clearly see the nucleus failing to provide some support to the bottom level (L5-S1) putting the level above and the spinal cord at risk. The surgeon who performed the surgery did not see any issue and told the patient that the device has no defect.

Is the M6-C Artificial Disc from Orthofix just as bad as the M6-L ?

We probably don’t need to answer this question. Pictures are just enough !

Orthofix M6-C
Orthofix M6-C. We can see the titanium enplates broken in pieces. How can this happen especially when the implant is so close to the spinal and put patients at risk of being paralyzed for life.
Orthofix M6-C. This the catastrophic outcomes patients experienced from the M6-C (Cervical). Patients had to go life threatening extensive revision surgeries. To this day Orthofix is still selling this disc when Australia had to modify the Information For Use because a recall would have been impossible as the implant is fused to the bone.

Orthofix keeps promoting the M6-C after so many failures:

That is the dream Orthofix has been selling to desperate patients.

JOIN US TO STOP ORTHOFIX FROM RUINING LIVES !

I started this blog after encountering a failure from the M6 artificial disc, a device made by Orthofix in Sunnyvale, CA. My initial thought when I started to experience the extreme pain from my failure from my two M6-L artificial discs was how can something that had supposedly been through rigorous verification and engineering occur just after a few months?

Spinal Kinetics, the M6 disc developer was acquired by Orthofix in 2018 was promoting their M6 disc as being the “best artificial disc on the planet”. A few surgeons in Europe such as, Dr Pablo Clavel from Instituto Clavel in Barcelona Spain, Dr Bierstedt from ONZ, and Dr Ritter-Lang from Germany promoted the Orthofix M6 disc for the sole purpose of making profits without considering patient risks. These surgeons have implanted thousands of these discs knowing the M6 disc have severe risks and adverse events reported. Here is a link of many failures from these different surgeons: https://doctorpabloclavel.wordpress.com/

M6-L From Orthofix. Countless failures all over the world and Orthofix is still selling the M6 disc and is even expanding in more countries. An M6 disc is sold for $8000 a piece charged to Brazilian patients (the cost of surgery is not included).

Orthofix using “Nike Marketing Strategy” to promote surgeries with the M6 disc

Laura Wilkinson, an Olympic Gold Medalist promoting a medical implant that has so many flaws

Laura Wilkinson is an Olympic Gold Medalist promoting surgeries using Orthofix implants just like all the Athletes do it for Nike. Is it ethical to promote a disc that has a design defect & failed on so many patients around the world ?

All things considered we have to keep in mind that Laura Wilkinson gives expectations to potential patients that are far from being realistic because not everyone is an Olympic athlete and most patients do not have the very close follow-up provided by Orthofix that Laura Wilkinson benefited from.

ON THE RIGHT SIDE WE CAN OBSERVE AN M6-C FAILED AND INFECTED.
Failure of the M6 Artificial Disc Made by Orthofix

The M6 disc, a device with many flaws !

At the time of my surgery the M6 was considered as the best performing disc on the CE market until a few failures happened. Many sidelined the issue of the manufacturer and put fault on the surgeons, however over the last few years an alarming rate of failures and adverse events have been reported.  Some patients [link] have even been paralyzed as a results of implanting of M6 artificial disc. It appears  the M6 disc have routinely failed in similar fashion as it becomes very unstable. Even these unethical surgeons’ conducting these surgeries were not the primary issue in failures .  However, the surgeons were well aware of the severe risks and the issues and yet, still continued to  implant thousands of disks all while grossing millions of dollars each year.

Orthofix, the manufacturer has known about the risks and adverse events but  still continue to aggressively  market the discs to any surgeons willing to implant them. Dr Pablo Clavel made a little bit more than €4 million per year for implanting an unreliable disc.

M6 artificial disc poor design putting patient at risks of being paralyzed or disabled !
The M6-L weakness of this design is represented by the friction of the fibers on the metal plates, a potential source of breakage or wear products. The risk is greater if the implant is facing atypical conditions of rotation or inclination in the frontal or sagittal plane. Another mode of failure can be the blocking of the core in flexion or in extension causing a limitation of mobility or abnormal stresses of the peripheral structure with lesions of the polyethylene fibers construct, risk of nucleus expulsion and direct endplates contact with metallosis.
Lazennec JY. Lumbar and cervical viscoelastic disc replacement: Concepts and current experience. World J Orthop 2020; 11(8): 345-356 [PMID: 32904082 DOI: 10.5312/wjo.v11.i8.345]

The M6 artificial disc has a faulty design that puts patient at increased risks of being paralyzed or disabled !

As illustrated in the figures above, the nucleus is encompassed by an artificial annulus made of rope keeping the nucleus inside and the design is the same for the M6-C (the cervical version) and the M6-L (the Lumbar version). This design made with a rope attempting to keep the nucleus inside the annulus has been extremely inconsistent.   There has been many reports of instability and yet Orthofix has publicly addressed the issue. Is it possible they are more concerned of making profits than the safety of their prospective patients?

Orthofix, M6 artificial disc failure

The M6 disc design has pitfalls and creates the same failures.

Here is just a sample of the disaster Orthofix has created by selling the M6 disc:

A poorly designed device ruining lives

A failure of the M6 disc over 42 weeks. You can see the implant is completely falling apart.

As you can see the rope holding the nucleus inside the device is so thin. How does Orthofix expect to keep a this rubber nucleus centered for 40 or 50 years when it fails after just 12 weeks as we have seen it on the pictures below.

ORTHOFIX ADVERTISES ON THEIR WEBSITE:

IS THE M6 REALLY THE SUPERIOR SOLUTION ORTHOFIX OFFERS TO PHYSICIANS TO IMPROVE PATIENTS’ LIVES ?

M6 Artificial Disc Failure, Orthofix. This failure happened on a young & healthy woman. We can observe a change on the core at 12 days post-surgery.

As illustrated in  these x-ray images the Orthofix M6  disc consistently  fails by triggering  instability as it has a weak core.

The level L4-L5 is very unstable on this picture not holding the spine up as intended. Here is a comparison of 3 different patients.  Patients had diseased natural discs taken out to replace them by defective artificial discs made by Othofix. What is the point of doing that ? The surgeons implanting these discs were aware of the flaws ! We can see the M6-L failed the same way on 3 all the patients.

It is apparent the M6 core is extremely weak.

Orthofix, M6 artificial disc failure

There are many more failures and could go on, but we think you got the point.. Here is an Xray of  the only patient who had 2 failed M6-L disc implanted by Dr Pablo Clavel and replaced by 2 LP-ESP by Dr Svante Berg.

As you can see on the picture above the M6 at L4-L5 failed completely placing pressure on the facet joints. The spine was completely unstable and collapsed from the back. Orthofix and Dr Clavel were stalling to provide any response or treatment for the failure that  the patient had to contact alternate surgeons in Europe to seek solutions. The patient received a revision surgery and as a result, the revision surgery confirmed the M6 discs had indeed failed.  Orthofix failed to provide a report detailing what happened and did not assist the patient in recovery from the revision.

Another point is very important: looking at the picture you can perfectly see that my spine had nothing to do with the failure as I am young and was in good shape. Comparing my spine with 2 M6 and my spine with 2 ESP shows how weak and defective these M6 discs can be but Orthofix does not seem to care very much about patients.

Orthofix, M6 artificial disc failure.

Dr Pablo Clavel himself explained to a patient the technicality of the poor design of the M6 disc.

This is just a good summary of what happened to all the patients showed above especially when Dr Clavel said that the “M6 has a tendency to bend to one side over the nucleus causing scoliosis”. All the surgeons who previously used the M6 disc in Europe and Australia have switched to the ESP disc because they noticed the M6 issues.

A young woman paralyzed from an implantation of the M6-C (Cervical)

Cathy had a one level M6-C implanted and right after the surgery felt some extreme pain. Dr Clavel ignored Cathy and did not provide assistance. The problem in this case is that the M6-C is 7 milimeters tall when a natural disc even on super tall people is 4 or 5 milimeters and surgeons using the M6-C stack this disc at 2 or 3 levels and it crushes the thoracic spine creating more protrusion, herniations and all kind of problems.

Here is how Orthofix market the M6 on their website:

Orthofix is saying that the implantation of the M6 avoid an adjacent level disease. Orthofix compares the M6 to a natural healthy disc and that’s another way for Orthofix to increase their sales. I will never emphasize enough on the the fact that the M6 disc does not even come close to a natural disc.

Here is an MRI proving that Orthofix misleads patients:

Here is another x-ray imaging of the same patient and the same level showed above:

Herniation on the thoracic spine is very rare because this portion of the spine does not move very much so we can easily believe that the M6-C and M6-L cause the bone endplate to cracked due to too much pressure.

Prior the artificial disc replacement surgery this patient had no degeneration on his thoracic. Many of the M6 patients had subsidence of the bone and herniation at adjacent levels.

Why did the FDA approve this device when so many failures have been seen in Europe ?

A NY State Trooper’s life ruined by Orthofix:

Very close pre-existing relationship between Dr Clavel, Dr Ritter-Lang and Spinal Kinetics Former CEO, Tom Afzal

Why would Dr Clavel and Dr Ritter-Lang implant the M6 Disc for a decade after seing so many failures ?

It seems Dr Clavel and Dr Ritter-Lang had a very close relationship with the Former CEO of Spinal Kinetics, Tom Afzal who recently joined NOVUM MEDICAL.

Here is the link of a picture showing Tom Afzal posing very close to Dr Pablo Clavel and Dr Ritter-Lang: 

Tom Afzal (on the left), Dr Ritter-Lang (in the middle), Dr Pablo Clavel (on the right)

Is there any incentive to implant the M6 disc knowing that Orthofix was prosecuted for paying illegally surgeons overseas ?

Orthofix ruining lives for profits !

Orthofix has continued to ignore the catastrophic outcomes of these patients’ failures. These M6 discs are marketed by surgeons like shady car dealerships. ONZ, a German clinic run by Dr Bierstedt, Dr Illerhaus and Malte Peterson even  came to the US to illegally market and  recruit patient  by holding “disc conferences” when they have no medical license in the US nor permission from the FDA to market a device that has not be FDA approval.

ONZ tours every year to recruit international patients and Orthofix is well aware of this unethical practice while they profit from having American patients going to Europe to get the faulty  M6 disc. Here is a screenshot of an ONZ event in Las Vegas and they have been back every year since:

ONZ has been selling a non-FDA approved device without a US medical license for years on the US ground. Surgeons implanting the M6 disc are far from being innocent !

“Savage and criminal Medicine”

Orthofix is currently looking for new surgeons in Europe to implant the M6 disc. Isn’t it unethical when the disc maker itself knows about the danger of implanting such a bad device ?

Orthofix is not reassessing the quality of the M6 implant. Orthofix Management organized a training in Verona, Italy to teach more surgeons how to implant the M6-L and M6-C knowing the M6 has a design defect.

Catastrophic outcomes for patients having a failure with the M6-C approved by the FDA:

Orthofix has been advertising that the M6 protects the adjacent levels above and under the M6 disc implanted because it offers motion but this is not we have observed with many patients having an M6 for a few years.

Many patients experienced some stenosis and also subsidence (cracked bone) on the adjacent levels. The extreme pressure patients felt with the M6-C can have a huge impact on the thoracic spine creating more problems, more herniation and arthritis. We have observed an accelerated degeneration on adjacent levels due to the 7 mm height of the M6-C when a natural disc is usually only 4 or 5 mm tall.

X-rays will be posted soon !

Podcast: A testimony of horrific outcomes of the M6-C

Relentless neck or back pain . . . with stabbing nerve pains . . . can be unbearable and debilitating. We try every alternative therapy until surgery becomes the last remaining option. If you are in this predicament, please listen to my story. It could just change your mind about your next steps. I’d like to provide you with the INISIGHTS and WARNINGS that I wish I had prior to going down the surgical path. My story is quite complex. However, everyone deserves the truth vs. only partial information, in order to make the right decision. Please be AWARE of the Orthofix M6 artificial disc replacement product that is available now in the USA. I believed this product was solid and fail-proof, but the exact opposite is true . . . .

The M6-C does NOT live up to their “motion for life” tagline.

https://www.londonspine.com/early-implant-failure-of-a-2-level-m6-cervical-total-disc-replacement-a-case-report/

CRIMINAL BEHAVIOR FROM ORTHOFIX MANAGEMENT TO MAXIMIZE PROFITS:

The U.S. Securities and Exchange Commission, known as the SEC, announced on Wednesday, 18, an agreement with Orthofix International, in which orthofix international admits to having committed accounting fraud and also having paid doctors in Brazilian public hospitals to use their products and thus increase their sales. The company has agreed to pay more than $14 million to close the investigations.

In a statement, the SEC said the Brazilian subsidiary of the medical equipment and accessories implant company had violated the Law to Combat Corrupt Practices Abroad (FCPA) by producing “a scheme with strong discounts and improper payments through representatives and distributors” to induce doctors hired by the Brazilian government to use its products. In Brazil, the case became known as the “prosthesis mafia”.

“Orthofix did not have adequate internal controls in its subsidiaries and failed to detect and prevent improper payments in Brazil that were intended to increase sales,” said Kara N. Brockmeyer, director of the SEC division that handles corrupt practices practiced abroad.

In the case of accounting fraud, the company would have recorded certain revenues before the permitted, or even recorded revenue even having granted customers a new deadline for payment. These errors would have made the company produce incorrect financial reports between 2011 and early 2013.

“The accounting failures were widespread and significant, leading Orthofix to issue false communications to the public about its financial conditions,” said Antonia Chion, associate director of the SEC’s enforcement division.

Of the approximately $14 million that will be paid by Orthofix, $8.25 million is due to accounting fraud and another $6 million in fines related to the FCPA violation. Four company executives also admitted guilt and received minor fines.

Orthofix admits accounting fraud and bribery to doctors in Brazil – ISTOÉ Independente (istoe.com.br)

https://norcalrecord.com/stories/510940055-suit-filed-against-spinal-kinetics-inc-over-m6-c-devices

FRAUD SCHEME AT ORTHOFIX INVOLVING FOREIGN DOCTORS

Orthofix has been selling the M6 disc in Europe for a decade and we have seen that Orthofix has been ignoring patients experiencing failures. Orthofix has been in the news a few months ago prosecuted for Fraud Scheme involving Foreign Doctors. Are spine surgeons such as Dr PABLO CLAVEL from INSTITUTO CLAVEL, Barcelona and Madrid Spain, Dr BIERSTEDT, Dr ILLERHAUS from ONZ based in Germany and Dr RITTER-LANG from Germany involved in this Fraud Scheme ? These surgeons have been working with Orthofix (Spinal Kinetics) for 10 years.

Here is another fraud involving Dr Ritter-Lang from Enande in Germany:

Stenum Invoice Scam – Getting ripped off before surgery.. (wordpress.com)

Orthofix has pleaded guilty for another Fraud Case in 2014

Divehttps://www.healthcaredive.com/news/physician-charged-in-orthofix-fraud-case/255541/

Medical Abandonment from Orthofix for all the patients who experienced a failure of the M6 Disc

Orthofix has been nowhere to be seen to help patients experiencing a failure. Here are several email and report sent by Orthofix to patients:

Orthofix sold defective design implants banned Worldwide to Brazilian Patients !

Orthofix knew about the design defect and all the issues as the device was banned worldwide but they still took the opportunity to sell it to Brazilians patients. Is Orthofix using some very unethical practices to take advantage of a very easy regulation to generate profits ?

Savage Medicine: Dr Ritter-Lang, a German Surgeon associated with Orthofix performs a revision of a Rainier artificial disc with an M6 disc.

How can Dr Ritter-Lang replace an old Rainier artificial disc that failed with an M6 disc that has a high probability to fail in the future when he dismisses all his M6 failures. This patient already had some serious damage. Even after the revision the patient is in a horrible pain and has an implant that has a high chance of failing again. Is there any common sense in Dr Ritter-Lang’s Patient’s revision assessment ? Does Dr Ritter-Lang care about his patients’ future ?

Dr Ritter-Lang has been dismissing his own patients having failures of the M6 disc for more than a decade and nothing in Germany has been done about it.

RHODA, A YOUNG WOMAN VICTIM OF A FAILURE OF THE M6 DISC NEEDS YOUR HELP TO HAVE A REVISION SURGERY

Orthofix has been repetitively commiting crimes. Here are all the links:

https://www.institutionalinvestor.com/article/b1ncw99y3m022q/Why-I-Broke-Wall-Street-s-Code-of-Silence

https://www.google.com/amp/s/mobile.reuters.com/article/amp/idUSKBN25S65Q

https://trofire.com/2020/09/15/whistleblowers-uncover-massive-fraud-scheme-at-medical-supply-company-orthofix/

https://www.fiercebiotech.com/medical-devices/ex-orthofix-manager-gets-home-confinement-medicare-kickback-case

https://www.massdevice.com/doc-indicted-perjury-connection-with-orthofix-investigation/

https://blog.volkovlaw.com/2017/01/fcpa-recidivists-orthofix-part-ii-ii/

https://www.modernhealthcare.com/article/20140423/NEWS/304239940/doctor-becomes-eighth-person-sentenced-in-sprawling-orthofix-fraud-case

https://archives.fbi.gov/archives/boston/press-releases/2013/another-orthofix-defendant-sentenced-for-committing-medicare-fraud

https://news.bloomberglaw.com/health-law-and-business/orthofix-to-pay-government-42-million-resolving-bone-growth-device-sales-claims

https://www.justice.gov/opa/pr/texas-based-medical-device-manufacturer-pays-us-34-million-settle-false-claims-act