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  #31  
Old 08-15-2015, 05:36 PM
dman777 dman777 is offline
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Quote:
Originally Posted by nihs View Post
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'm surprised as well that this hasn't generated more discussion here.

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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prior to 2015: happy go lucky, no health issues
2015: left arm pain, diagnosed with two herniated discs (C5-6 and C6-7), with mild cord compression at C6-7 but no direct symptoms from that (yet?)
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  #32  
Old 08-15-2015, 07:48 PM
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jss jss is offline
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Quote:
Originally Posted by nihs View Post
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.
EXACTLY! I have two M6's circa Nov 2009. If, may God forbid, I needed another fusion/ADR, I would not consider an M6 until I got to the bottom of this problem. The hearsay of this problem is that Spinal Kinetics knew about this problem and fixed it. I don't know if that's true or not, but am left to wonder if my pair of M6-C's are of the defective variety, or the fixed variety... I don't know.

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:
Originally Posted by ilva View Post
Hello everyone! It's been a while since I reported on the progress. Last Stand had been / autumn last summer that the symptoms became more violent (including spontaneous vomiting in tilt / inclination of the head, electricity, hardly possible seats , enormous head pressure ....). Initially it was already established in the fall of 2012 in front of my treating physicians that the M6-C prosthesis on c5 / c6 now "no function" would be and through the larynx downward-knit top and base plate " immobile " . The neurologist did it again writing notes that the base plate "protrudes into the spinal canal radiologically". The MRI was indeed caused, but with respect. To the affected segment C5 / C6 was only stated that there would be "artifacts" and thus in any case only "restricted would be assessed". Then everything else fizzled. Despite increasing complaints it was only that one could just leave so .... ??? Only offered me my orthopedist - after several PRTs - still on, among other things, to make the head nerve block stationary. Accordingly, I was last unsettled, especially since I just felt the successive aggravations and tried to portray this plausible ... Fortunately, then turned my (very good) Physio and advised me to comprehensive clarification in the neurosurgery Bochum . There finally beginning in October 2013 showed that CT + MRI suspicion of a "mass" into the spinal canal into - well above the base plate ...: ph34r: Therefore you have advised me to myelography. This then confirmed the suspicion, no doubt, that the prosthesis CORE had drilled into the spinal cord to the rear (up to 8mm) and the Spinalkinetics M6 prosthesis destroyed was. According to urgency, I was advised to remove all material. So I stayed the same for OP ( today - fortunately ...). However, one pointed but also that it would not be clear what you would find exactly the OP. Accordingly, it had until then 'not similarly stored incident "documents given ... This one had assumed that I would have to be opened anteriorly and posteriorly -. Associated with autologous bone harvesting from the iliac crest and subsequent merger with titanium cage including plating shuddered - but I had little choice in the state ....: hair At the end of October was all broken prosthetic material - very skillfully - away. Today I can talk about a bunch of luck and skill very good specialists, Prof. Schmieder and OA Dr. Barth. After the operation I was feeling despite merger namely immediately better. The most extreme symptoms were directly after waking up - about all for 6 weeks - away. Ultimately, I may be more than grateful and glad that in fact only the ventral access was necessary. The core could be luckily from the front "hold", after they had been working carefully through the broken parts to directly to the spinal .. I am very aware that the whole thing would completely differently out -: B I will here give anyone discomfort, the date a "dynamic prosthesis" bears. Still, she was with me well "dynamically" ... (even though I had an accident or other incident / fall, etc.). Nevertheless, you should know what is very possible. To what extent the manufacturers product, or the center should have been better back up, would be an interesting question. I guess I'm going to this - by appropriate means -. nor respect exactly ... (the removed material has now after several odysseys with me) Certain damage Although I have long suffered, but still not the last OP is yes so long ago. That takes up and I should have a little more patience. Some of the symptoms is - depending on the form on the day - but sometimes still being felt. But maybe regenerates a part? At least it was said that the main purpose of the OP avoiding the worse served - everything would now also better, I therefore see it as a GIFT. In rehab I will not put myself for the time being. My physio helps me tremendously about the current phase of time. In any case, should anyone whose plates are also grown together and / or otherwise wrong are somehow - IMMEDIATELY initiate a comprehensive CLINICAL DIAGNOSIS OF A COMPETENT SOURCE and "put off appeasement" not with. Normally you yourself very good feeling when an exacerbation feels seriously. All the best wishes - and that they either never require a prosthesis or who she carries on, he / she receives so good controls. AP Greetings from Ilva
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C4/5 - ACDF in 2000
C5/6 - ACDF in 2002
C3/4 & C6/7 - M6 ADR, Nov 2009, Barcelona
Conceded defeat to a manifestly disingenuous BCBS-TX in my quest for reimbursement, Jan 2011
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  #33  
Old 08-15-2015, 11:10 PM
drewrad drewrad is offline
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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...
__________________
Weightlifter since 12 years old, now mid-40's and figuring out this wasn't such a good idea.

Chronic back pain started in 2010 while shrugging weights that a 40 yr. old shouldn't even try.

MRI in 2012 showing L4/L5, L5/S1 herniations and L2/L3 bulge.

L5/S1 taking on new shape, chronic sciatica, etc.

DEXA bone scan performed 5/7/14 showing mild osteopenia.

Surgery performed July 9th, 2014, Dr Clavel, hybrid three level lumbar.
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  #34  
Old 08-16-2015, 10:22 AM
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jss jss is offline
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So one shouldn't get to the bottom of these two similar sounding failures before receiving an M6?
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C4/5 - ACDF in 2000
C5/6 - ACDF in 2002
C3/4 & C6/7 - M6 ADR, Nov 2009, Barcelona
Conceded defeat to a manifestly disingenuous BCBS-TX in my quest for reimbursement, Jan 2011
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  #35  
Old 08-16-2015, 05:51 PM
Cheryl0331 Cheryl0331 is offline
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Join Date: Dec 2010
Posts: 836
Default 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.
__________________
53 yr old female 5'7" 141 lbs. non-smoker conservative treatments failed
2007 fusion @ C4-6 peek cages, failed due to long term use of cox-2 inhibitor
2008 revised C4-6 donor bone, plate & screws
2009 fusion with Roi-C @ C3-4
2015 MRI & CT mjr ddd @ C6-7, segmental kyphosis at C7-T1, 2-level M6-C prosthesis by Dr. Clavel Barcelona Spain
2019 H.O. formed behind M6-C @ C6-7 left nerve rt & in spinal canal.
2020 Revision C6-7 to a cp-ESP prosthesis by Dr. Schmitz Dusseldorf Germany
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  #36  
Old 08-16-2015, 07:10 PM
drewrad drewrad is offline
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Quote:
Originally Posted by jss View Post
So one shouldn't get to the bottom of these two similar sounding failures before receiving an M6?
Its not what I said. You know that.

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.
__________________
Weightlifter since 12 years old, now mid-40's and figuring out this wasn't such a good idea.

Chronic back pain started in 2010 while shrugging weights that a 40 yr. old shouldn't even try.

MRI in 2012 showing L4/L5, L5/S1 herniations and L2/L3 bulge.

L5/S1 taking on new shape, chronic sciatica, etc.

DEXA bone scan performed 5/7/14 showing mild osteopenia.

Surgery performed July 9th, 2014, Dr Clavel, hybrid three level lumbar.
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  #37  
Old 08-16-2015, 07:20 PM
drewrad drewrad is offline
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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.
__________________
Weightlifter since 12 years old, now mid-40's and figuring out this wasn't such a good idea.

Chronic back pain started in 2010 while shrugging weights that a 40 yr. old shouldn't even try.

MRI in 2012 showing L4/L5, L5/S1 herniations and L2/L3 bulge.

L5/S1 taking on new shape, chronic sciatica, etc.

DEXA bone scan performed 5/7/14 showing mild osteopenia.

Surgery performed July 9th, 2014, Dr Clavel, hybrid three level lumbar.
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  #38  
Old 08-19-2015, 04:49 AM
nihs nihs is offline
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Quote:
Originally Posted by Cheryl0331 View Post
2 M6's surgeries out of the 30 thousand implanted is good numbers.
I seriously hardly doubt there's only been 2 people that had their M6 ADRs fail. Two is just a small sample size based on information found online, just like only a very small percentage of the people post their post surgical outcomes online. If everyone reported it and they were all successful we would have approximately 15,000 to 30,000 different people posting information on successful post surgical outcomes... just saying
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C3-C4: 2mm central protrusion
C4-C5: 1mm central protrusion w/ annular tear
C5-C6: Disk mildly narrowed; 1.5mm central protrusion; Uncovertebral joint spurs that mildly narrow right and moderately narrow the left nueral foramina
C6-C7: Disk mildly narrowed; extensive modic type II endplate changes; 3 mm central protrusion which extends into the uncovertebral joint spurs; Moderate canal stenosis. Uncovertebral joint spurs that moderately narrow the neural foramina bilaterally.
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  #39  
Old 08-20-2015, 02:10 PM
firefighter firefighter is offline
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Join Date: Jul 2015
Posts: 9
Default 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!
__________________
retired firefighter 2011
4 ADR in 2007 at Stenum, Germany
M6 @ C4/5 & C5/6
Maverick @ L4/5 & L5/S1
Both M6 are broken, found out April, 2015
Both broken M6 removed, C5 vertebral body removed, front and back fusion of C4 to C6, July 2015
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  #40  
Old 08-20-2015, 10:18 PM
Cheryl0331 Cheryl0331 is offline
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Join Date: Dec 2010
Posts: 836
Default yes, true

Quote:
Originally Posted by nihs View Post
I seriously hardly doubt there's only been 2 people that had their M6 ADRs fail. Two is just a small sample size based on information found online, just like only a very small percentage of the people post their post surgical outcomes online. If everyone reported it and they were all successful we would have approximately 15,000 to 30,000 different people posting information on successful post surgical outcomes... just saying
I should have elaborated a bit more on my commit. out of 30,000 implants; of those, the ones that are on this site, we have two patients...THAT WE KNOW OF.
__________________
53 yr old female 5'7" 141 lbs. non-smoker conservative treatments failed
2007 fusion @ C4-6 peek cages, failed due to long term use of cox-2 inhibitor
2008 revised C4-6 donor bone, plate & screws
2009 fusion with Roi-C @ C3-4
2015 MRI & CT mjr ddd @ C6-7, segmental kyphosis at C7-T1, 2-level M6-C prosthesis by Dr. Clavel Barcelona Spain
2019 H.O. formed behind M6-C @ C6-7 left nerve rt & in spinal canal.
2020 Revision C6-7 to a cp-ESP prosthesis by Dr. Schmitz Dusseldorf Germany
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