VIPER2 STRAIGHT ROD-80MM

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. D2: ADDITIONAL PROCODES: KWP, KWQ, MNH, MNI, NKB. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. 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.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT CST AFTER THORACIC SPONDYLODESIS TH11-L5 WITH NON-SYNTHES SYSTEM IN EXTERNAL CLINIC, TIME UNKNOWN, DATE UNKNOWN. IN (B)(6) 2024, SACRAL FRACTURE TREATMENT WITH VIPER SAI SCREWS AND EXP CONNECTORS TO EXTEND DORSAL SPONDYLODESIS TO LUMBOPELVIC FIXATION. REVISION SURGERY WAS PERFORMED ON (B)(6), 2024, DUE TO DISLOCATION OF THE LUMBOPELVIC STABILIZATION. THE RIGHT ROD SLIPPED OUT OF THE VIPER SAI HEAD, THE LEFT ROD SLIPPED OUT OF THE EXP CONNECTOR, HERE THE INNIE WAS LOOSENED. THE CONNECTORS WERE FIRMLY FIXED ON BOTH SIDES OF THE NON-SYNTHES CONSTRUCT. DURING THE REVISION SURGERY ON (B)(6), LONGER RODS (100 MM) AND NEW INNIES WERE USED. THE VIPER SAI SCREWS WERE LEFT IN PLACE AS THEY WERE PROPERLY ANCHORED IN THE BONE. THIS REPORT IS FOR A VIPER2 STRAIGHT ROD-80MM. THIS IS REPORT 7 OF 7 FOR (B)(4).