A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation was completed as the lot number has been identified/confirmed in this case.Since the screw remains in the patient, no physical, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.It was reported that multiple instruments could not engage and fully lock the screw.It is likely that the lips of outer collet became compromised at some point during the case.Once compromised it becomes difficult for instruments to fully engage onto the screw head.However, without the actual implant no definitive root cause can be determined.Our investigation and review of the manufacturing and inspection records revealed no manufacturing discrepancies or material defects, nor did it reveal any contributing information/trends.Remains in patient.
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