5046796|24757923|N|1||DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UNKNOWN WHEN SCREW BECAME LOOSE AND BACKED OUT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN. THE LOT NUMBER PROVIDED COULD NOT BE VERIFIED; THEREFORE, FURTHER INVESTIGATION CANNOT BE PERFORMED. ONE OF THE FOLLOWING DEVICE(S) WAS RECEIVED: 4.5MM VA-LCP CURVED CONDYLAR PLATE (PART # 02.124.411 | LOT # 9237095); 5.0MM CANNULATED VA LOCKING SCREW (PART # 02.231.690| LOT # UNKNOWN); 5.0MM CANNULATED VA LOCKING SCREW (PART # 02.231.685| LOT # UNKNOWN); 5.0MM CANNULATED VA LOCKING SCREW (PART # 02.231.680| LOT # UNKNOWN) - QTY. 2; 5.0MM CANNULATED VA LOCKING SCREW (PART # 02.231.675| LOT # UNKNOWN); 5.0MM VA LOCKING SCREW (PART # 02.231.244| LOT # UNKNOWN); 5.0MM VA LOCKING SCREW (PART # 02.231.238| LOT # UNKNOWN); 4.5MM CORTEX SCREW (PART # 214.842 | LOT # UNKNOWN); 4.5MM CORTEX SCREW (PART # 214.836 | LOT # UNKNOWN). A TOTAL OF ELEVEN (10) IMPLANTS WERE RECEIVED. ALL DEVICES SHOW SIGNS OF BEING IMPLANTED. THE PLATE IS INTACT WITH COSMETIC SCRATCHES ALONG ITS SURFACE. ALL NINE (9) SCREWS HAD DAMAGE TO THE STARDRIVE RECESS CONSISTENT WITH INSERTION AND REMOVAL. THE THREADS ON 42MM CORTEX SCREW WERE ROLLED. THE EXACT CAUSE FOR THE SCREW LOOSENING COULD NOT BE DETERMINED. A VISUAL INSPECTION, FUNCTIONAL TEST, COMPLAINT HISTORY REVIEW, AND A DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. SINCE NO X-RAYS WERE RECEIVED, THE COMPLAINT CONDITION WAS UNABLE TO BE CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.