Open letter to Orthofix
The manufacturer of the two M6L Artificial Discs I have in my lumbar spine
June 29, 2022
What happened to me needs to be prevented; it should not happen to any other patient.
The ADR Surgery I had at ONZ Spine in Germany ruined my life and robbed me of my ability to work to provide for my family and for myself. I cannot longer do it. I am not able to obtain any gainful employment anymore, due to pain and limitations caused by the failure.
To Orthofix: Have you done anything at all to prevent it?
I know you are disputing the Devices were non-conforming, defective, or failed in any manner. But have you done anything to investigate my “allegations”?
They are not allegations; I live with them every day.
Have you reported to any regulatory agencies that a patient with two M6L implants had his life ruined because of the ADR failure?
And also that that patient needed several surgeries to stabilize his back; have you opened an investigation?
We can work on the hypothesis that your Medical Devices are conforming, non-defective and have not failed in any manner. Let’s then work on the root cause of the failure. Improper patient selection, improper medical device selection and improper surgical technique by the surgeon.
If this is the case, have you contacted Dr. Thomas Bierstedt and stopped selling him the M6L?
The answer is NO, he continues to advertise the M6L and for him it is business as usual. What happened to me and to other patients with failed ADR did not affect his business at all. Neither it did to yours.
Have you opened an adverse event case for all patients who have reported failures?
Are you doing anything at all to prevent this to happen to others?
Since we had communication for the last time, I have had three more surgeries related to the ADR failure and the last one was just only three weeks ago.
The M6L Artificial disk that you are disputing is “non-conforming, defective and that failed in any manner” has ruined already three fusion processes. Its core still exerts arbitrary forces on my spine and has loosened lumbar hardware three times.
I know you will try to get out of this with a legal technicality but what about responsibility, morality and accountability?
You took advantage of my limitations and pain, the financial hardship the ADR surgery caused me, along with my inability to return to work and obtain gainful income to provide for my family and myself. For you it has been just business as usual but for me it is a daily struggle with pain and limitations and the fact that the two M6L manufactured by you here in the US continue to harm me and my health.
Your medical devices and the unethical surgeon you continue to sell to, ruined my life. You have not done anything to prevent him to do the same to other patients and you have not investigated at all what happened to me, what it is still happening to me as I unfortunately still have the two useless artificial disks in my spine.