It was reported that the patient operated with expedium 5.5 ca 1 year ago.The rod had slipped out of the patient, leaving the construction not satisfying.Patient was fine for the first months after first surgery.Then after a while he got more back problem again.Reoperation shows that some of the sets screw on the distal part of the construction was not that hard to open (seemed like they were not as tight as they should be, final tightening was done by doctors during surgery first time).On the right side the rod was just inside the distal screw, almost on it-s way out as well.Construction was from l2 to s1 with ilium screws bilat.The one ilium screw the whole tulip just had loosen from it screw and was hanging on the rod, without being on the screw itself.During surgery (today) they were tapping with a 10 mm tap before putting in 10x80 viper cortical fix screw in the old ilium fixation (they took out 9x80) the two polyaxial screw driver broke, and the viper screwdriver.The viper part got stuck in the screw while it was half way in the bone, they tried to take i out, but with no luck, leaving it to no other chose than saw of the part that was outside the bone, leaving the rest in the patient.Then they took a exp verse below that (8x80) with success.Final tightening after rod insertion.Some of the sets screws that was taken out had some marks on them.
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Product complaint # = > (b)(4).Visual examination of the single-inner setscrew revealed signs of operative use as evidence by superficial markings, with threads and drive feature slightly worn.It was noted that the rod striations were observed on the set screw suggesting that the set screw were seated properly.A functional analysis was performed with a poly-axial screw and x25 inserter from which it was noted the set screw could easily threaded into the screw head.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A functional analysis was performed with a poly-axial screw and x25 inserter from which it was noted the set screw could easily threaded into the screw head as well as rod striations were observed on the set screw suggesting that the set screw were seated properly.The investigation could not verify or identify any evidence of the instrument contribution to the reported problem.It is not suspected that the instrument failed to meet specifications.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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