EVENT DATE: UNKNOWN. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SERVICE HISTORY REVIEW: PART NO: 324.06, SERIAL/LOT NO: (B)(4): NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 27 MARCH 1997. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
D
Patient 1
IT WAS REPORTED THE DEVICE HAS A MISSING SET SCREW. THIS OCCURRED DURING TESTING, NO CASE OR PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).
N
Patient 1
SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE SET SCREW WAS MISSING. THE REPAIR TECHNICIAN REPORTED MISSING PARTS AS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: SET SCREW. THIS ITEM WAS REPAIRED, PASSED SYNTHES FINAL INSPECTION, AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. (B)(4).IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.