This report is being resubmitted for an incident that occurred earlier.The device was not returned for evaluation.It was determined that the screw head had not detached post-operatively, but was not fully attached intra-operatively.If a screw head is able to detach from the screw shank without any reduction force, it is likely that a head inserter was not used.The head inserter must be used before any screw head is used in surgery.However, the exact cause of the reported issue could not be determined.The following sections have been updated for this supplemental report: b4, h2, h6, e1, h10.
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