L4-5 Charite ADR Stenum

[trkdoc714]

I'm very sorry for your suffering and continued pain. However, the beginning of this thread is not factual. I'm sure there many failed surgeries. Try to remember, this is elective surgery. There are risks. We're made aware of these risks. There will be failures, there's no way around that. Each of us has taken that chance in the hopes we'll be healed.

As far as the beginning of this thread goes, just go back and look at one thing. The story begins with the surgery being performed in October of 2005. Why does the film of the explanted disc have a date of July 2005 stamped on it?

I truly hope and pray you find a pathway to recovery. Living in pain is horrible.

Bob

[Kathy]

Originally Posted by trkdoc714

The story begins with the surgery being performed in October of 2005. Why does the film of the explanted disc have a date of July 2005 stamped on it?

Wow, you are observant! I completely missed that and I looked and looked at those films!

I would like to know the answer to this as well?

Anyone know?

[mmglobal]

John's surgery was in October of 2004 as Havanna stated in her original post. It looks like the 2005 date is a simple typo.

Why now? Because kc0iet recently sought me out and I suggested that others could benefit from her experiences. Havanna's post is self explanatory. How does she have his films? Because patients email xrays and compare. I also have John's films. Willie's got 'em. So do Vikki, Carmen, Fred and probably many, many others. How do you know they are not some random films taken from the Charite' lawsuit? I knew John personally. They are his films. You may choose to believe or not believe whatever you think appropriate.

I'm sorry that some find this unpleasant. This is not good for the industry, not good for the site. It's great for the patients that it helps. It's not great for the patients that it hurts. I'm sorry that this caused such anxiety for Bob and his wife. There is no way for me to time what other people post and there is no good time. It is what it is and we all have to be adult and understand that internet information is a mixed bag.

People who remember all the way back to my original ADR forum that was the predecessor of this forum and adr support... back pain support group had a thread about Fred's subluxated core. Stenum's representative did come and explain. You'll see that he said:

Originally Posted by ADR-Jim on September 23, 2004

Please don't believe everything you hear, Fred's core did not "pop out", the lower plate failed to adhear to his previously fused vertebrea. A risk they knew of prior, he will have fusion at that level and ADR above in Oct. Also it is my implant on getadr.com and I am now 18 months with no pain, skiing, tennis, soccer, lifting up to 80lbs, no problems.

A risk that they knew of prior? One would think that if they were concerned about such a complication, they might have implanted the disc with the front teeth actually having some purchase in the vertebral body instead of hanging off the edge. Positioning is discussed more, below. (Here is the original thread from back in 2004) Back Pain Support Group: Charite core popping out???? Note that the thread was started by ADRJen who is a successful Stenum patient. She was the first person I called when I resurrected the surgical outcomes posts that I had started at BPSG. Here is her update: ADRJen Charite L5S1 Aug.2003.

Yes, I called Cindy when she posted that she was going to have a total hip replacement, but I remembered her positive SI injection. I suggested that she get evaluated by someone who has a 'bigger picture'. Based on her response, I offered to connect her to someone who specialized in SI joint dysfunction. She has now canceled her hip replacement surgery and has had a much smaller surgery that seems to have resolved her pain. She chose her path with a small assist from me and we have no idea what the future holds. Had I not called her, she would have endured a total hip replacement, and presumably the pain that was resolved by the SI surgery would still be there. I think I have 100 of her dollars.

Yes, I called Bob to convey what I know about Stenum. If anyone thinks that there is a difference between the call to Cindy and the call to Bob, that's fine... I can live with that. Some people may call this marketing. I'm either blessed or cursed with this mission and have never made a profit at this. I have not been paid by the doctors. (Bob, you should not post things that aren't true and you should question the motivation of those who are telling you things that are not true.) I have only worked for the patients.

I don't know why anyone would suggest that the death was "twisted into placing the blame on Dr. Ritter-Lang." What was posted was, Unfortunately, remaining in chronic pain and the stress of the ordeal took it's toll on John and his pain problem turned into a drug problem. The drugs took him from us.

Regarding positioning of the disc: from the Charite' installation manual (2004):
> page 13, step "confirm positioning": The Centre of the artificial disc should be 2mm dorsal of the sagittal midline. (this 2mm posterior positioning is restated on page 14 also)

> page 14, step "endplate insertion" - Load the selected endplate into the endplate insertion tips placing the more angled of the two endplates inferiorly.

> page 17, step "final positioning" - Verify the final position of the Charite' Artificial disc using flouroscopy. It is important that the prosthesis is in the correct position in the AP and Sagittal planes. If necessary, the position of the prosthesis can be altered by slightly using the appropriately sized Grooved Driver. In the event of a gross malposition, the entire prosthesis can be removed and reimplanted, by reversing the previous insertion steps.

There are three grossly malpositioned discs pictured on this page. One of them resulted in a successful outcome. Two of them resulted in disastrous outcomes. I wish I could say that the steady flow of these types of failures from Stenum has stopped, but it hasn't. I have clients with similar problems with Mavericks and M6 discs too.

Regarding the angled plates. The side of the plates with the teeth that provide the bone / metal interface are identical on the angled and flat versions of the plates. Endplate shape, density, etc are not relevant issues with regard the angled plate being up or down. It is about bringing the plates parallel to each other and perpendicular to the load that will be placed on them. Bob, would you share the documentation that says the plates may be reversed? The design of the Charite' has changed somewhat. Perhaps a different device has different technique. In any case, I'd love to see what you have. I'll be happy to share the 2004 installation manual if anyone likes.

When you stand on a chair, do you put your foot in the middle of the chair of all the way on the very edge? Would you rather the chair be on level ground or on a hill. What if you stand on the downhill edge of a chair on a hill? Don't take my word for any of this... ask an engineer.

I know a lot of happy Stenum patients and I look forward to hearing about the success of both Bob and his wife. They have every reason to look forward to success. As I've always maintained... properly implanted in a properly selected patients, all of the designs will be fine.

Sorry for the disjointed ramble... I have tried to address all the questions raised. It's been a long night. I hope this helps to clarify some things. I have more to say, but have to go.

Mark

[mrbee]

Wow! What a series of posts. What perspectives on the history of Stenum. For those here who don't know me I am MrBee (Willie). I rarely post anymore here or anywhere. Mark once told me that when a spiney resumes living again that he/she stops posting. He is right.

My friend Mark was to meet me last Thursday, he called me at 6am to tell me he could not make our breakfast meeting, he had just booked flights to Germany in two days! This was so he could have a very scary cervical mulit level ADR. Hard for me to believe. I posted to him once I read his post surgical report, then I found this thread. Whoa am I in pain, not physical (I do have those intense memories) my heart is in tears for Stenum failures.

I knew Fred, Carmen, Rina, John, Rob, Charlie and others. All of us passed through Stenum. Some names of folks here who have all had revision surgeries. There are others who through my ordeal have contacted me directly. I have kept those folks confidential.I know of others who have had surgeries with surgeons here in the US that have had revsions. It happens in this highly risky world of man's attempts to artificially alter the human anatomy.

I wish to make known that indeed during my time at Stenum, and subsequent to that I knew of failures. During that era, all reports, articles etc referred to the single digit percentage of failures using the Charite device. Remember in 2004 the device was not yet approved in the US. So it was difficult to obtain much info on it. I found Mark who incredibly had had this same surgery. After speaking to him I felt OK to seek this German made technology. There was no iSpine or GPN then, just Mark a real passionate human who was helping others. By the way who here would like to help those like us who even after putting all our hopes into our seemingly only choice of radical surgery that can end horribly be there for us after? Mark does this with compassion. I found the Stenum webpage, contacted the success stories and spoke to the Director and based my decision on this, plus never ending pain!

As to my story, I am not a medical theroist. I am really bad on all these highly technical aspects of implantation, translation, lateral movement, etc. I am a simple man, who underwent a most incredible journey. I personally witnessed several immediate failures in my window of time at Stenum. Those days of old of countless hours or days spent on the computer or phone talking to so many people who had been to Stenum and were still suffering. I sought like others for an end to my horror, post my fifth surgery to be wheelchair and bed bound. On 240 plus mg of morphine daily (no typo) along with a boxful of other high powered meds.

To witness the trail of those who contacted me for solace or venting was and still is a watermark in my life. I have nothing to compare it too. Yet it happened. All of it. Why? Was it surgeon error? The device? Greed? (packing 10 to 15 Americans in a week when the German/others count was far less). Or something more than this?

It was surreal. I have prayed for Stenum for Dr. Ritter-Lang, for Dr. Zechel to stop whatever was happening. I am not like Mark, he had devoted his life to helping those like all of us to find the best choice for our surgerical decisions. I did not use or pay Mark to help me choose Stenum. He thought I was OK to make my own choice. Once my world was shattered with a failed outcome (surgery #4) I asked Mark to come with me to Stenum for my revision. He was amazed that I would invite him (I had paid for my neurosurgeon to come to my ADR surgery in August, he backed out at the last moment).

Mark and I discussed the thousand questions to ask Stenum about my upcoming rare if not unprecendented revision surgery. I was glad to have Mark with me. I value those people who have such real insights/intellect whom can help me through my life or business decisions. Mark was a beacon of light to me when all was dark. During our flight over, Mark shared his life and new passion with me. I suggested to him that he should do this. Accompany people like me to Germany and advocate for them in a foreign country in a foreign hospital environment. Only after my horror that was days away did Mark experience firsthand that epihany to stand up and tell the world about these experiences.

I do not have all the answers. For the fellow who had his surgery at Stenum (trker I think) I am thankful for you and your family that you are doing well. I pray that Stenum has a zero failure outcome. I wish there was actually zero failures in any of these horrid surgeries anywhere. It is a tough road to hoe to experience pain and suffering. I have gone through what few have. John was one. Rob another. Fred is still alive and lives on massive drugs. He has been throuh detox twice, what an insidious cycle.

I have not nor choose to stay up on the ongoings of the ADR world and Stenum. It is like a bitter time for me to reflect. However, it is part of my life. My life today is based on this experience. I do not know of any one who has my same story. From deaths door to a miracle. I can only live like you each day in wonder. My body is healed, pain free, drug free. Like surgery never happened. It is sureal.

My heart goes out to Havanna. You are a dear to recall John. I remember when Carmen flew to help John in a dark time. Folks there are many stories of compassion thoughout this world of spine surgery and life. John was like us. He made a decision that led to his ulitimate death. I know of others who have never posted anywhere, that went that way too. I was ready too, only God intervened.

This is a long post but important, not to bash Stenum, but to shed some light on the history of the events in 04. Has Stenum changed, yes. Are they free of failures? No. Is the percentage of failures like 04? I do not know. Who would know? My view looking back is this, I would hope that either with these horror's I witnessed personally and my pressure on Stenum through De Puy made Stenum "correct" the internal problems.

Does a forum like this with a thread like this help? Absolutely. Does it polarize us with opinion of course. Pro and con. I love some of the folks at Stenum. The Backenkohler is the best memory. The countryside of Stenum is outstanding. The other side though is troubling or was. Or could still be. I can only hope that for anyone reading my post that you consider carefully wherever you have surgery. Know the risks, ask questions, assume nothing, ask about failures. Ask for cetificates or credentials. This is your life in a surgeons hands, he or she will not or should not be offended. If they are, then run from that one.

Lastly, I appreciate that Mark had allowed this important thread to stay up. Other forums have closed threads like this. Is it only the Stenum aspect? Or is it a man who has helped in a world of hurting humans. Where it is easy to vent and post our intimate feelings/emotions, especially when we are in pain. My did I recluse in that world of misery. I could not even watch TV and see normal happy people doing the things I would never be able to do. I hope that did not strike to hard of a nail with some of you in that exact place. I lived it. I know it. I am thankful to God for His gift to me and my family. I am thankful for Mark as he really stands alone in helping us to wade through this world of hard choices.

I pray for Mark to recover and resume his place on the forum. I pray that this forum continues to thrive.

Willie
MrBee

[New-disc]

Mr. Bee,

Thanks for your story, it's very well written.

Todd

[dshobbies]

Willie,

I don't know if you remember me but while knee deep in the rocky road of spinal remedies and ready to head off to Stenum because they came up first on my google search, you took time to tell me your story, and others, and steer me to Mark. I don't even remember the forum where I first posted but you were there and began my education. I am forever grateful and thank you for sharing your story once again.

You minimized the horror of your story. Those who don't realize that your very life was at great risk also don't understand why we feel the need to warn others about Stenum's history. Your suffering lay at the hands of your trusted surgeon and he betrayed that trust. Once trust is broken, it can take a long time to rebuild it, if ever. And for those who feel we are bashing a good doctor or hospital, that trust has yet to be rebuilt. Our only understanding of someone choosing Stenum is that they don't know what we know. If you and others didn't help educate me, today I might be one of their hidden statistics, excusing my failure as a difficult case that no one else would take. If posting on this or other forums, I feel it is now my responsibility to pass on this knowledge so others can also decide for themselves with a more complete knowledge base. I'm sorry if this hurts others but knowledge is power, both good and bad.

For those successes at Stenum, I'm truly happy for you. I just don't understand why, if going all the way to Germany, anyone wouldn't put their spines in the capable hands of those surgeons considered the best in the world, Dr. Zeegers (not practicing at the moment) and Dr. Bertagnoli.

BTW, I read an article about cardiac surgeons in the paper this morning and a new success rate transparancy. It said the transparancy wasn't important for separating the great doctors from the good but for weeding out the bad.

I am not any kind of expert in anything medical. I hope Stenum has improved their surgical techniques and skill but that is something everyone must decide for themselves, with as full a knowledge base as is possible.

Thanks Willie, Dale

[Kathy]

I think we all agree that one must research and make the best choice that they can.

There is no way for us to know a dr's true statistics. Maybe that is something that we as a spine community could fight for and try to get. Real statistics from all doctors and hospitals.