The device was not returned for evaluation.The build lhr for 1842868 (b)(6) was examined including the final inspection records and the in-process measurements.There was no ncmr associated with this lot.The device met the m6-c product specification including the axial stiffness and flexural resistance specifications.Risk management files were review and no new risks were identified.Rmf 0003 rev 38 line 12.75 - device explanted.It was reported that an m6 artificial disc was explanted and it was noted that the proper procedure for this patient was and acdf.Radiographic images were not provided for review.Microbiology/pathology reports and results were also not provided.The device was not returned and therefore examination of the explant could not be completed, therefore it is not possible to determine the cause of the reported failure for this product experience.
|