5.5 EXP VERSE FEN SCR 6.0X45

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: H3, H6: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION, THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS REQUIRED AT THIS TIME. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED PATIENT UNDERWENT THE REOPERATION ON (B)(6) 2023 WITH L3-S SCREW REMOVAL, L2/3 TLIF (NON-JJ PRODUCT: TRITANIUM), L2-SAI SCREW INSERTION (JJ PRODUCTS: VERSEFS, EXPEDIUM DI, AND EXPEDIUM SAI). ON (B)(6) 2025, A L1/2 TLIF WAS PERFORMED DUE TO ADJACENT SEGMENT DYSFUNCTION. L2 TO SAI WERE LEFT AS IS. VERSEFS (1.8CC CEMENT EACH) WAS USED FOR L1, AND RISE (GLOBUS) WAS USED FOR L1/2. CRANK RODS (NUVASIVE) AND ROD CONNECTORS WERE USED TO CONNECT TO THE EXISTING RODS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE SALES REP RECEIVED A COMPLAINT AFTER A CT SCAN ON (B)(6) 2025, SHOWED BILATERAL BREAKAGE OF THE L1 SCREW IN A PATIENT WHO UNDERWENT L1/2 TLIF (VERSEFS + RISE (GLOBUS). THE SCREW BROKE NEAR THE LATERAL HOLE OF THE SCREW. IT IS CURRENTLY UNDECIDED WHETHER OR NOT TO PERFORM SURGERY ON THIS PATIENT IN THE FUTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT AND (B)(4) REPORTS THE REVISION SURGERY PERFORMED ON (B)(6) 2025 WHILE RELATED (B)(4) REPORTS THE BREAKAGE OF THE SCREW OCCURRED AFTER THE SURGERY PERFORMED ON (B)(6) 2025.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.