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#31
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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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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?) |
#32
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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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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 |
#33
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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...
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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. |
#34
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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 |
#35
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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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54 yr old female 5'7" 147 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 |
#36
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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.
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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. |
#37
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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.
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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. |
#38
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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. |
#39
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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!
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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 |
#40
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yes, true
Quote:
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54 yr old female 5'7" 147 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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