This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation in the locked position.There were minor signs of wear upon one of the clamps and there were marks on the saddle where the rod made contact.There is also wear on the top of the rod where the locking caps were engaged and signs of wear upon both of the bottoms of the locking caps where they contacted the rod.There is a significant amount of wear along the threads of one of the locking caps and both locking caps have thread shavings present.Finally, there is a small amount of biomaterial stuck between the saddle and the tulip.It is possible that biomaterial was between the clamp and the screw head or that it lodged between the saddle and the screw head during assembly in-situ which caused the saddle not to lock properly.However, no determinations could be made as to the cause of the reported issue.The following sections are been updated: b4, e1, h2, h6, h10.
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