Quote:
Originally Posted by nihs
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.
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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.