EXPEDIUM VERSE

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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THIS WAS A PLIF (L2-S) FOR LUMBAR SPINAL STENOSIS ON (B)(6) 2026. DURING THE FINAL TIGHTENING PROCESS, WHEN THE SET SCREW WAS TIGHTENED, THE THREAD WAS DAMAGED, MAKING IT IMPOSSIBLE TO COMPLETE THE SPECIFIED FINAL TIGHTENING. THEREFORE, THE AFFECTED SCREW WAS REMOVED AND REPLACED WITH A NEW SCREW. AFTER REPLACEMENT OF THE SCREW, FINAL TIGHTENING WAS COMPLETED WITHOUT FURTHER ISSUES THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. NO ADVERSE EVENT TO THE PATIENT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.