Quote:
Originally Posted by JeffR
No worries we've all been there.
One thing though - it is true that the FDA testing is more stringent than European testing to get approval for implantation, however in some ways this is a BAD thing in that it takes soo much money and time that good products like the M6 just can't get approved (yet).
I would look at the 10,000+ M6s installed as a pretty good sample set though, you basically have to scour to get a bad result and it is always surgical error, there is no evidence of device failure at this point.
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That is only part of it. Prodisc immediately sues for patent infringement any time a new disc tries to come into the US!
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Multiple traumas to spine starting age 13.
1st American to have 6 ADR's in one surgery. C3-4 - C/7, & L5-S1 - L3-4.
Surgery w/ Dr. Clavel, 3/18/13, M6.
Before surgery: severe spinal stenosis C5/C6 (cord "flattened" per stateside doc), + for Hoffman's & Babinsky's.
At time of surgery: 5 yrs MAX before ending up in wheelchair.
Clavel found L5-S1 partially fused. Had to cut it apart to put in M6.
Please excuse brevity - SEVERE carpel tunnel.
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