Removed Devices
 

I believe a lot of device manufacturers require return of the device to the company, upon removal, for testing & analysis.

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.

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?

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!

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?