ONZ spine is actively promoting surgeries in Canada for patients to travel to Germany. They are doing it at strategically picked airports where they can see also US patients and patients from other countries. They are receiving medical records, assessing patients and recommending surgical procedures. In a few words, they are breaking the law by practicing illegally in Canada.
Open letter to Orthofix
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.
Update recent surgery
I had yesterday surgery number six after the hack ADR surgery done by Thomas Bierstedt from ONZ in Germany (not calling him Doctor anymore as he did not deliver a standard of care at all). All those surgeries were done to try to fix his wrong doings on lumbar spine and Abdominal anterior approach. I stated to try to fix as the damage he did left me beyond repair on my spine and with a deformity on abdominal wall. He destroyed my career and therefore took away any possibility for me of gainful employment. Medical device manufacturers should stop selling to him the implants as the way he does his procedure causes severe harm to patients. He caused me severe harm and I cannot provide any longer for my family or for myself. Medical device manufacturers should also reevaluate their devices as the ones implanted in my spine caused me scoliosis and other severe damage and due to the conflicting forces they exert have ruined two fusion processes and lumbar hardware. Do I need evidence to prove this gross failure? Well, I have all the evidence I need of it. I am condemned to keep them as long as live even if they are useless since day one. Attempting to explant them will put me again at life threatening risk. That hack surgery left me with irreversible nerve damage, permanent limitations and constant and severe pain. All that could have been avoided if Bierstedt would have paid attention to my multiple reports of complications but instead he put other non medically qualified individuals to tell me everything was fine. Nothing was fine. They should have intervened and fix their wrongdoings but they chose instead to downplay the importance of my reports to the extent of demeaning and insulting them calling it speculative worries. They also threatened me of stoping any and all post op care. I didn’t received any anyways. There was no complication protocol in place and there was no second line of defense as they post in their advertising. Thomas Bierstedt, Malte Petersen and Jack Lemon should not be allowed to make decisions involving medical procedures or treatment. They are vulgar criminals that robbed me of my quality of life and my ability to work. And they know they are untouchable as no regulatory agency or government had acted to investigate and stop their wrongdoings. Vulgar criminals and the cowards who never took ownership of their wrongdoings; they chose instead to betray my trust and to ruin my life. I will not stop denouncing them and exposing them and if only one patient pays attention at a time and steers away from them, it will be a patient spared of living this nightmare of pain and limitations I live and experience every day.
Complication Management Protocol
Another lie from Spine Connection and ONZ.
There was no complication management protocol in place and if it was, it was completely ignored.
Many times I reported the excruciating pain and limitations I was having every single one of my reports was ignored and demeaned every single one of them.
Malte Petersen even called my reports “speculative worries”. I was not speculating. There was something clearly wrong and all the people involved in my surgery just ignored the complications I was having. The complication that could have been addressed properly and perhaps further damage could have been prevented.
Jake Lemon from Spine Connection just called them “it is normal”, “just breathe and push through the pain”. And he always shielded ONZ and Dr. Bierstedt. Bierstedt was never available to respond to emails or to take my calls asking for support on the complications.
I was having all those complications due to Dr. Bierstedt doing my surgery wrong and choosing the wrong artificial discs.
I wasn’t safe at all. And you Jake Lemon are a complicit of all that. You are as responsible of it as the surgeon is.
You both robbed me of my ability to work and provide for my family. The surgery was a complete fraud and affected my spine to the point of rendering me unable to work due to pain and limitations.
The surgery that was done wrong by dr. Bierstedt and it forced me to have numerous surgeries to try to stabilize my back and to repair the abdominal damage done during the anterior approach.
You both are criminals of the lowest kind. You both ruined my life.
I will continue exposing my case and your wrongdoings. I have the evidence, all the evidence is in my body, as you Dr. Bierstedt condemned me to have two useless M6L inside of me for the rest of my life; all for the sake of money. You ruined my life and you Jake Lemon are a complicit of it.
Your miracle surgeon is the criminal who ruined my life…
It is now two years and six months since I had the Failed Artificial Disc Surgery at ONZ Spine in Germany, botched by Dr. Thomas Bierstedt.
My life changed radically since. I could never go back to gainful employment to provide for my family and for myself. My life now, is full of physical limitations and permanent pain.
All those issues could have been prevented if Dr. Biersted had done his due medical diligence to assess my case. He ignored the evidence in the imaging studies I submitted and proceeded to a contraindication surgery and with this, he ruined my spine and therefore my life.
Yes, the miracle surgeon for some is the one who ruined my life. I have received messages and comments telling me how good Dr. Biersted is and how much he has helped his patients. And also telling me that what I am saying is not true. All I know is he took my money, abandoned me as a patient having complications after him botching a surgery and ignoring my multiple requests for support, follow up and corrective measures for what he did wrong.
He forced in two inadequate artificial discs and to make them fit in the intervertebral space he over-distracted the vertebrae causing severe nerve damage. The surgery was a failure leading to increased spine instability and a scoliosis I didn’t have before.
He might have helped many other patients and I am glad for them, but he failed me miserably. When I was in excruciating pain due to the botched surgery and the medical devices harming my spine, I was wondering what was happening to me. I made him aware multiple times of it and desperately asked for support assessing the situation and to proceed; accordingly, he never replied. Instead, he put his attack dog Malte Peterson to insult me and my concerns to the point of threatening to stop care if didn’t desist of asking for follow up care. He even disrespectfully and in adversarial manner called my requests for follow up and support “Speculative worries”.
If Dr. Bierstedt had acted upon my requests I would probably not be in the situation I am in now. I had to go through multiple surgeries to try to repair the damage Dr. Bierted did to my abdominal during the anterior approach. He severely damaged the abdominal wall, causing with this several hernias that had to be repaired surgically. I had also two lumbar spine surgeries to stabilize my spine with hardware and I am in line to one more withing the next three weeks.
The erratically and abnormal functioning of the two artificial discs had ruined twice the hardware put in place to stabilize the lumbar spine. Those two useless M6L discs cannot be explanted without seriously putting my life at risk. Dr. Bierstedt with his hack surgery condemned me for life to have inside of me, two useless artificial discs that are doing more harm every day.
We are all humans and therefore we can make mistakes, but when it comes to severely affecting the health and life of a patient, taking ownership of a wrongdoing is expected from the medical professional to preserve and improve life and of course to correct what was done wrong. Dr. Bierstedt never took ownership of his wrongdoings and never offered any solution to help me as his patient. This fact is the complete opposite of what they say regarding their second line of defense when complications arise; I notified them multiple times since the early post op stages and they just ignored my situation and completely dismissed me from any care and follow up. I was told many times by Jack Lemon, the Spine Connection Patient Liaison, that I was safe and covered… I was never safe and now I am worse than before ADR. They ruined my life. They are vulgar criminals who should not be dealing with patients and surgeries. For me, Dr. Biersted is a hack surgeon. Malte Peterson is an arrogant and disrespectful thug. Jack Lemon is an unprincipled business man who chose profit instead of helping a patient in need of support.
Those are the criminals who ruined my life and took away my ability to work and provide for my family and myself.
The European Union regulatory agencies and the German authorities are also complicit as they don’t intervene when such surgeons harm patients for profit. They just let them do whatever they please. There is no accountability at all.
Illegally diagnosing patients in USA and Other countries.
ONZ has visited the US to recruit potential patients. They are not licensed to practice in the United Sates but they diagnose and many times misdiagnose patients. That is a violation of their admission as visitors; they have and continue to break the law.
European Union regulatory agencies are just an ornament…
Why the EU regulatory agencies ignore the negligence cases reported? It shouldn’t matter if the patients are not EU citizens or residents; human beings are being injured by hack surgeons like Dr. Thomas Bierstedt and authorities do nothing to stop him.
Open Letter to ONZ, DR. Bierstedt and Jack Lemon – Spine Connection
Dr. Bierstedt and Jack Lemon,
You both lied to me.
Dr. Bierstedt was incapable of addressing my concerns with an adequate standard of care. Instead you put Malte Peterson your fight dog to downplay and insult my concerns to the point of calling them speculative worries.
You, Jack Lemon told me I was safe and that you had my back as I was under your umbrella.
All those were lies; gross lies and gross negligence.
Yes, you had my back and took it away from me; you took away my ability to work and provide for my family and myself.
The M6L failed due to the reckless way you implanted them and that and caused me numerous irreversible issues. I have permanent nerve damage due the way the discs were implanted and the irresponsible lack of due diligence when reviewing my images. You over-distracted my spine to force the discs in and that was the reason of the excruciating pain. You disregarded my spine condition for the sake of profit and while taking a monetary gain, you took away my health and ruined my life.
You both are criminals; the criminals who ruined my life.
I am still in the fight of exposing you, your organization and your negligence.
It should have been so easy to listen to what I was experiencing and I reported to you so many times. Instead of listening and acting immediately to prevent further damage you chose to dismiss me and to threaten me. That is utterly criminal.
I just hope people and authorities will listen and you both can be taken to law and be charged accordingly. You are not fit to diagnose patients and to practice surgery on them. People make mistakes and correct them but your arrogance left me with a ruined spine with two useless implants for the rest of my life. Two useless implants that are still causing me great harm.
International patients have no legal protection in Germany when complications arise.
Patients having complications are on their own once they leave Germany. And doctors know this fact well. Post op support is nonexistent. The same doctor that was readily available for the initial assessment and very quick diagnostic, is then nowhere to be found or too busy to answer calls, return messages or reply to emails. All this happened to me with Dr. Thomas Bierstedt from ONZ SPINE in Germany.