Upon evalauting the returned device, it was noted that the screw was not returned with the kerrison.Without the screw it is difficult to tell if there was any damage to the screw as a result of screw removal at some point.However, there were weld marks where the back of the screw would be that indicates that the screws were properly welded into place.As a result of the evaluation, a true root cause could not be determined.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions, a follow up report will be submitted.
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