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new here, first post
First, thanks to all of you who are sharing your knowledge and expertise. My name is Tim. I am a former Marine (3 years) and a retired firefighter (33+ years). I have had back trouble for what seems like my whole life, until age 53. I am 61 now.
Messed up the back in 2007 doing God know what, its not like it was something new to be in pain again... it was however worse than my normal pains. Progressed rapidly to the point that I needed a wheelchair to get in to see my doctor. She ordered me to start using pain pills which I hate and avoided at all costs prior to that. Long story short, my wife found Stenum doing an on-line search for artificial disc replacements. Went there in November, 2007. Had 2 M6-C ADR placed at C4/5 and C5/6 and 2 Maverick ADR placed at L4/5 and L5/S1. Surgery done Nov. 29th. Flew back hope mid December. Recovery was slow but steady. I returned to work as a full time firefighter after 6 months with no restrictions at all. Knew it was a miracle for sure. Jump forward to late 2013. I started having random pains in my left arm and shoulder. Along with that was getting numbness and tingling in half of my left hand. Had a few doctors try to figure if out. Did physical therapy, had trigger-point injections done, X-rays and MRIs taken. Saw specialists in Seattle with little help. Went back to a spine doctor in Spokane who had another set of X-rays and an MRI done. He believed there were bone spurs along C 4-5-6 which were causing the pain, numbness. Scheduled surgery to clean the spurs up on April 29, 2015. Surgery started well, as in on time, and when he got into the c-spine he immediately found a piece of loose metal debris, which he removed and he then closed up the incision. Good and bad of that. All the problems with the left shoulder, arm and hand were gone! The metal debris was believed to be from the M6 at C5/6. So, off for a CT scan. Results... both M6 are broken, the annulus of both appear to be gone. There is at least 1 more broken piece that can be seen on the CT that is still in the area. C5 and C6 both appear to have lost their density. Osteolysis I think it is called. They are not viable and will have to come out along with the ADR. I get to talk to a surgeon at University of Washington Spine and Joint Center July 10th. Both Dr. Ritter-Lang and Dr. Bertagnoli have offered to do this revision surgery, but being retired, I am not sure I can afford either of them, so may just stay in the States and have a fusion of some type done. Anyone who has been through this and has some ideas or suggestions to share, please let me know! Thanks again for having this site here to offer help, ideas and sympathy for all the spine problem sufferers out there. |
so sorry to hear that
Hi firefighter, my thoughts will be with you as you deal with this.
I'm new here as well, and just in the process of researching options for my recently diagnosed C5-6 and C6-7 herniated discs. Until now, all indications were that the M6 discs were the most promising and reliable, so I read your post with some shock. Given that you went back to firefighting after your surgery in 2007, I assume there was some significant stress placed on your spine over the years after that? Or did you try and take it easy? And was the surgery done by Dr. Ritter-Lang or Dr. Bertagnoli? |
Hi firefighter,
May I ask which if the surgeon you spoke with at the UW was with UW/Valley Medical Center? Just curious because my spine surgeon is with UW/Valley 😉 |
GinaMarie1221 and dman777
GinaMarie, I am not at the valley location. I saw Dr. Wagner last month and will see Dr. Hoffstetter this Friday. I believe he will be my surgeon. I am going to the Spine & Joint Center on Roosevelt in Seattle.
dman777, I worked for 3 more years after my surgery in 2007. Dr. Ritter- Lang did all 4 of my ADR. From what I have seen and read recently, I think the newer M6s are pretty good. I have heard there were some problems with the earlier ones (like mine). I assume they have made some improvements to the M6 ADR as they get more data on how they work for the patients. Dr. Bertagnoli has never liked the M6, Dr. Ritter-Lang thought it was the best cervical disc in 2007. I didn't do anything different when I went back to work, and it was my knees that forced me to retire when I did, not the back or neck. Best of luck with whatever you decide to do. |
Just a thought
Hi Firefighter,
Sorry to hear about your situation. I too met with Dr Wagner.. Great guy.... Just a thought, there is a Dr.Richard Wohns from the Seatttle Area, supposed to be a super good ADR surgeon, might be worth a shot for an appointment with him to get his opinion? Best of luck and prayers to you on your healing. |
Hi Iron
I did send a copy of my CT to NeoSpine in Seattle with a cover letter asking if they would be interested is seeing me as a patient. One of my good friends had a single level fusion done by Dr. Tredway last year and he is very happy with the outcome. I never got a response from anyone at Neospine. It may be that they are very busy or that they just did not want to do the mess that my neck has become. Thanks for the prayers!
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Any pics to post
Firefighter,
Very sorry to hear your situation. Any way of sharing/posting a couple of screen shots of the broken M6's. I am sure many of us would benefit from seeing this as it would concern those that are done and any that are contemplating. Be well and speedy recovery! F |
Oh this is not good. I am so sorry to hear of your complications. Please keep us posted on how you proceed. In the meantime I am sending positive energy your way.
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I had my ADR with Dr. Jason Thompson with Proliance Orthopedic Associates at UW/Valley Medical Center. He is fellowship trained and is the Director at the Joint and Spine Center. Just a suggestion if you're looking for options or second opinions :-)
Gina |
Dear Firefighter, I am sorry about your complications with the M6, and will prey you find the right solution and be pain free again soon. I have read that the M6 design allows for revision and be replaced with another M6 (new model), but not sure if the condition you described may limit this option! And of course for another M6, that means going abroad again and the high cost associated. Please keep us updated & best wishes.
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Thanks for the well wishes
Well, we met with Dr. Hofstetter at UW on Friday. My wife and I both liked him and liked his ideas for treatment. He is opting for a more conservative approach than we had gotten before. He does not want to remove either C5 or C6. His idea is to remove both M6 ADR and to clean up the damaged vertebra, remove all the bone spurs (which there are a lot of), put screws and an anterior plate in C4, C5 and C6. He believes there is enough viable bone in each of the vertebra to position screws to hold them in place. He will also put in something similar to stem-cells and bone-growth material to help the bones grow back and to fuse together, (made sense when he explained it, but I didn't follow all of it well enough to properly relay it here). We will give it a couple months to grow together and see how it is doing. If he is not happy with the bone growth, then we will have to have a posterior cage done in that area, (more painful and longer recovery). So that's the plan for now. Surgery set for the 23rd. Prayers for my wife to get over her bronchitis before that so we can get this done then!
I will try to get some pics of the broken discs posted. Not sure if that is within my computer skill set :laugh: but will try. Thank you all again for your well wishes and prayers. |
Tim,
What a terrible story. Thanks for posting it. You are the second poster we've seen here that has had a failure of an M6-C proper. The other failure sounded the same as yours; the annulus had migrated out of the implant. Per his account, Spinal Kinetics claims to have fixed that problem. I got my pair of M6-C's two years after you got yours. I am left to wonder if I received the one with the problem, or the one with that problem fixed. Osteolysis is not uncommon with some form of heavy metal poisoning; which is why MOM (metal on metal) hip implants have fallen out of favor. Since the annulus migrated out of at least one of your implants, you probably ended up with the M6's metal end plates articulating against each other. I don't know if osteolysis resolves when the metal source is removed. Since your new doctor wants to anchor screws in those thinned bones, it sounds like he believes it should. Wishing you the very best of luck on the 23'rd. Please update us when you're able. (looking forward to your images of the failed M6's if you can get them up) Good luck! |
oh goodness!
This is so horrifying! Like JSS; I too have MC-6 at two levels. Mine are under three level fusion which may make the stress on these devices even greater. So much for due diligence. I am due for my three month post op x-rays soon. My daughter in law worked for a PA that did a research paper on the M6-c and was going to do my x-rays for me but now he has left that hospital. Now I am on my own...I had no pain for two straight week and this weeks it's back.
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the 2nd?
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Surgery this Thursday - July 23
Here's what we have decided to proceed with: the doctors chart notes -
We are hoping for the best possible outcome. I had a long discussion with the patient and his wife regarding surgical options. I propose to remove the artificial disks. I am going to remove the anterior osteophytes at from C4 to C6. Reconstruct the bony defects using allograft spaces. I am also going to use vivigen allograft with immature osteoblasts to help with the fusion and reconstructing the bone mass. If the anterior construct appears to be solid I think there is an 80% chance to avoid posterior fusion. In case the anterior graft is not solid the might proceed with an immediate posterior fusion procedure. I told the patient and his wife that complications this procedure include infections, CSF leaks, permanent or transient neurological deficits. There is also a risk dysphagia and hoarseness. There also is a risk of nonunion. I told the patient at this approximately 20%. If the patient's signs of nonunions at the 3 months follow-up I would then proceed with a posterior fusion construct. Also told the patient is a chance of plate fracture screw pullout. Is also risk associated with anesthesia such as stroke death and blindness. The patient and his wife agree, asked appropriate questions and were willing to proceed. |
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firefighter, good luck Thursday!
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Firefighter ~ I'm so sorry you have to go through this again. I'm keeping you in my thoughts and prayers and wishing you the very best possible outcome from your surgery! Let us know how you are doing.
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The numerous bone spurs sounds as if no bone wax was applied on the posterior rim which for the cervical is a no no. Unless R-L did apply it and they formed anyway?
What specifically did Spinal Kinetics do to their device in the intervening 2 year period to strengthen them from their first gen iterations? Anyone know? Weird that metal would crack off. That sounds awful. I'm glad you're getting this revised! Try to get the doctor to keep the M6Cs once removed for observational purposes. |
I have an understanding that bone wax can only be applied on the anterior side of vertebra at least in cervical spine.
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Removed Devices
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It might be a good idea to try and get pictures if you can. |
My thoughts and prayers go out to you firefighter on Thursday. Good luck.
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Post Surgery update
Hi all,
Thanks for the well wishes and thoughts. I had surgery on July 23rd, at the University of Washington. Scheduled for 5-6 hours... took just over 9! What a mess. Doctor described C5-6 area to look to be full of shrapnel from the "exploded" disc at that level. Both discs were trashed. Removed them (C4/5 and C5/6) along with what was left of the C5 body. Now have a cage with bone chips to help the front fusion grow from C4 to C6 along with a metal plate for the front of the neck and 2 rods with 6 screws fusing the back side. Doesn't feel great, but at least I don't feel like my head may fall off or I will become quadriplegic if I trip and fall or have a minor car accident. Pain was very bad first couple days but mostly tolerable since then. Came home on the 27th and am slowly mending. If we figure out a way to get and post some pictures of before and after the surgery, we will do so. Hope no-one else has this type of outcome! Take care, Tim |
question
"Jump forward to late 2013. I started having random pains in my left arm and shoulder. Along with that was getting numbness and tingling in half of my left hand. Had a few doctors try to figure if out. Did physical therapy, had trigger-point injections done, X-rays and MRIs taken. Saw specialists in Seattle with little help. Went back to a spine doctor in Spokane who had another set of X-rays and an MRI done. He believed there were bone spurs along C 4-5-6 which were causing the pain, numbness. Scheduled surgery to clean the spurs up on April 29, 2015." Q: why didn't this debris show on the x-ray at this time?
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also my other questions
1. who was the surgeon at Stenum? 2. have you considered the fact that the surgeon who did the April 2015 surgery may have damaged these since they don't have experience operating around them? I am having anomalies even now short three months out from having had surgery and my implants looked good just a few weeks ago in x-rays. My daughter-in-law is a PA for a neurosurgeon and she said they are perfect. 3. what did Ritter and Bertagnoli say about this ever happening with the M6 before? I have not ever read such a thing posted about the device.
I am just having trouble with the fact that this didn't show up in those x-rays if it looked like "shrapnel" as they said it did? I am due for my three months post op next week. I will keep everyone updated.... |
about your neck feel like it could snap
I know all to well what that feels like. I had to cup my head in my hands at work as it felt like it would just plop over. I feel stronger than before; at least I have that. My neck muscles have really gotten better. I do a lot of isometrics!
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Answers for Cheryl 0331's questions
Hi Cheryl,
"Jump forward to late 2013. I started having random pains in my left arm and shoulder. Along with that was getting numbness and tingling in half of my left hand. Had a few doctors try to figure if out. Did physical therapy, had trigger-point injections done, X-rays and MRIs taken. Saw specialists in Seattle with little help. Went back to a spine doctor in Spokane who had another set of X-rays and an MRI done. He believed there were bone spurs along C 4-5-6 which were causing the pain, numbness. Scheduled surgery to clean the spurs up on April 29, 2015." Q: why didn't this debris show on the x-ray at this time? The major part of the debris was I think, from the annulus which is not metal and has no visibility on x-rays or CT scans. As to why the other pieces did not show, I would guess it was because of the view angle or just not knowing exactly what was being looked at. 1. who was the surgeon at Stenum? Dr. Ritter-Lang did the surgery in 2007 at Stenum. 2. have you considered the fact that the surgeon who did the April 2015 surgery may have damaged these since they don't have experience operating around them? The surgeon in Spokane based what he was trying to do on the MRIs which showed lots of bone spurs. He did not go into the disc space, but rather found a loose piece on metal he assumed was from one of the discs that should not be where it was, lying loose at a nerve bed. I am having anomalies even now short three months out from having had surgery and my implants looked good just a few weeks ago in x-rays. My daughter-in-law is a PA for a neurosurgeon and she said they are perfect. 3. what did Ritter and Bertagnoli say about this ever happening with the M6 before? I have not ever read such a thing posted about the device. Bertagnoli has said from the get-go that the M6 is unstable and would not hold up in use. Both he and Ritter-Lang said the bone was extremely deteriorated and needed to be removed along with "both broken M6 ADR." I am just having trouble with the fact that this didn't show up in those x-rays if it looked like "shrapnel" as they said it did? The majority of the shrapnel was like plastic, and had appeared to have caused the bone issues. Both doctors sounded like this was not something new to them. I know all to well what that feels like. I had to cup my head in my hands at work as it felt like it would just plop over. I feel stronger than before; at least I have that. My neck muscles have really gotten better. I do a lot of isometrics! I was mostly worried because the German doctors stated my neck was very unstable and could collapse for little or no reason. I was very pleased with the doctors and staff at the University of Washington. Dr. Hofstetter did the surgery. They will do some testing to try to figure out what happened and why the bone was so badly effected. Hope that helps clear some of this up. |
Tim,
I hope you are feeling better after one week post-op! Please tell us more when you feel like it. :) Curious question: did your docs ever discuss the removal of any of the hardware down the road after healing? |
Worse and better too ;-)
Hi Harrison,
I am much better than the first few days in the hospital. I have a lovely collar to wear which I am already very tired of :laugh: Really seems so very wrong to have so much pain and stiffness to recover from a surgery that I had to have even though I was in no pain for almost 3 months after the one in April where the doc found loose metal at C4/5. That said, I think I am a little bit better each day and will be very happy to ditch the collar when I can. The docs at UWMC did not discuss removing any of the new hardware with me. If doing so means I get to feel this good again, I think I would rather just keep it in where it is. I am not sure any of it can come out. Maybe if the front fusion grows solidly, then the back side stuff could come out. I think I would opt to leave it alone rather than open it up again anyhow. Slow and painful to heal the back of the neck if it is opened. The doc was hoping originally to not have to do the back as well as the front but decided it would be too unstable after having to remove the C5 which was soft and looked like swiss cheese. While I am not happy with all the restrictions (collar, no lifting over 8 lbs, no driving) at least I figure they will all go away in a couple months and I can get back to doing the things I like. This too shall pass and I will go fishing again! |
Surprised that more people have not chimed in on this discussion
I'm really surprised that more people have not chimed in on this discussion with the number people that have the received the M6 disc on this forum.
I've been on the fence of going overseas to get the M6 disc implanted for my C56 and C67, but reading this thread is getting me worried about the longevity of this device- which has been the reason why I haven't taken the plunge, even though my back neck and back discomfort is at times unbearable. There is no information on the web of re-design or possible defect with this device. If there are such inherent design issues with an earlier versions, then the company should let people know that the earlier versions are prone to such failure since a failure within your cervical spine can have serious or catastrophic effect. At least this will let them be aware of the potential risks, and let them decide to have more frequent check-ups or even a revision surgery. Firefighter had 2 of these implanted, and both failed not just one. This is a SERIOUS design flaw. All I hear from people is that their surgeons (or the person that spoke with spinal kinetic executive) that they have no history of device failure - which is pure BS. Sorry...I've been on this forum for quite sometime, and I've been trying to filter through all the information that people post on here. When the manufacturer and doctors are presenting false information to the patients then they are misleading the patients w/o presenting the potential risks. This is completely irresponsible. Is the End-of-Life (EOL) of the M6 7-8 years? What happened to the 80 year simulation testing that was done (is this for version A, B, C, etc)? I'm wondering if this is the reason for Spinal Kinetics withdrawing from the FDA approval process some time ago. Now, they are back at it trying to get this device approved again. If failures such as this happened and surgery took place in the states, then these are major lawsuits for this approximately 10 year old company. Don't get me wrong... I think the M6 design is quite innovative. Who would not want disc replacement that replicates your original disc (or close to it). The longevity of this device is the real question is in my mind. Anything and everything breaks down overtime. I'm sure the M6 works great when they first insert it into your spine (it's like getting a brand new pair of shoes), but what happens after 10, 20, 30, 40 years, etc? |
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There was one other documented case, in Germany, where an M6 failed, resulting in posterior extrusion of the artificial annulus, and supposedly the response from Spinal Kinetics was that there was a design change that would prevent that in newer M6s. I also can't find any reference to any M6 design improvements anywhere, and wonder whether that would actually be possible with FDA devices in general, without having to go through new clinical trials and approval process. |
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The other M6 failure that came across this forum a year or so ago, was similar to firefighter's story; only worse. After much searching I've finally found the German forum where the patient with the M6 failure posted his story first hand. Here is the link. Below is the output of google.translate of the patient's story. I hope someone out there knows German and can do a better translation for us. You can go to that page and translate the whole discussion. Quote:
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Well isn't that a tough read? It was like Yoda talking or listening to Led Zeppelin albums backwards but the gist was; core expulsion to the posterior, annulus failure.
Who knows, maybe the thing was adversely inserted or perhaps early iterations engineered incorrectly. All I know is that I have seen failures of other ADRs, keep that in mind. I have seen ProDiscs absolutely destroy people. I have seen fusions absolutely destroy lives, as well as better lives. I have seen failures of the Charite. Broken pieces extruded on the operating table. I have seen horrible images of the Activ L gone awry. Dr. Clavel told me face to face, the M6 is the best ADR right now, bar none. He was not a salesman. He would have put an Activ L in me as well as I instructed him to have both on standby but he pleaded with me to go with the M6 due to, in his clinical opinion, it being the industry leader. He also told me that the reason why he fused my L5/S1 is that ANY ADR would fail if the sacral slope was steep like mine, fixed core or non. If you are questioning the device, look at Braulio Estima who was thrown on his head in an MMA cage. His cord looked like the letter Z. He was nearly paralyzed on impact. Two M6Cs later, watch what he does. He rolls on the jitz mats at full speed driving his forehead into opponents chests. He also bridges at workouts. Full bridge, no hands! I've seen the videos as he's a FB friend. He places his weight onto his skull and works his neck muscles, straight up. That should be enough to tell you what you need to know. I am BTW still waiting for firefighter to post his images. Not doubting him, but we have asked him several times now... |
So one shouldn't get to the bottom of these two similar sounding failures before receiving an M6?
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what I hear Drew saying is...
Some tend to go at post op like they never had surgery and over work their necks to much. ADR's are artificially strong; probably stronger than a real disc, but that doesn't mean you should push it to the max. We have someone here that just had the axiomed freedom disc go bad after 8 months. 2 M6's surgeries out of the 30 thousand implanted is good numbers. Dr. Clavel also has access to the Baguera disc too. I feel that he truly does believe the M6 is the best. But he's open to using others if needed.
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Get to the bottom of all options, all ADRs, all fusion options etc. The fact that the FDA approved ProDisc has damaged a lot of folks here is not speculation. I do not like that device, but if others want to investigate it they have every right just as the M6. I am not making up what a well respected as well as ethically inclined, world renown super neurosurgeon(super because he trains other neuros) told me sitting across a table from him. He has far more access to real stats than anyone else short of SK themselves. Indeed, they harvest a lot of feedback from Dr C's work re the M6 in the field both during implantation and years of postop followups. insecurity is always to be expected. I should know. I have two M6Ls. |
BTW, me asking for pictures is to help investigate the very issue for those both deciding preop as well as those already in, postop.
Wondering why its taking so long. Hope you're doing well Jeff. |
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Pic's I hope!
I seem to be healing up fairly well. The collar I have to wear isn't super comfortable, but I am sure there are others that would be much worse. Pain from the surgery is mostly gone and I am doing good, still not supposed to drive as turning to see the traffic at intersections is still not easy to do. I will try to attach a couple pics to this, one from before the revision surgery and one with my new stuff. Hope this works.
I guess someone needs to tell me how to attach a picture to this. I selected 2 and tried to attach them but neither shows up. Help! |
yes, true
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