M.U.S.T. POLYAXIAL PEDICLE SCREW

Description of Event or Problem

REVISION SURGERY DUE TO TWO SCREWS LOOSENING AT L2 AND SCREW BREAKAGE AT L5 AT 1 YEAR AND 3 MONTHS FROM PRIMARY.THE PATIENT WAS HEAVILY BUILT AND HAD DENSE BONE. IT IS NOT KNOWN WHICH LOT THE BROKEN SCREW BELONGED TO, NOR WHICH LOT THE LOOSENED SCREWS BELONGED TO. EVENT RELATED TO THE SAME PATIENT OF THE MDR (B)(4).

Additional Manufacturer Narrative

SINCE IT IS NOT KNOWN WHICH LOT THE BROKEN SCREW BELONGED TO, NOR WHICH LOT THE TWO LOOSENED SCREWS BELONGED TO, THE BATCH REVIEW WAS PERFORMED FOR ALL THE IMPLANTED LOTS. BATCH REVIEW PERFORMED ON 08 JUN 2026 PEDICLE SCREW 03.50.020 PEDICLE SCREW 6X55MM + NUT (1X) (K121115) LOT 2126365: (B)(4) MANUFACTURED AND RELEASED ON 06-DEC-2021. EXPIRATION DATE: 2026-NOV-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.50.020 PEDICLE SCREW 6X55MM + NUT (1X) (K121115) LOT 2321694: (B)(4) MANUFACTURED AND RELEASED ON 21-MAR-2023. EXPIRATION DATE: 2028-MAR-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.50.020 PEDICLE SCREW 6X55MM + NUT (1X) (K121115) LOT 2228604: (B)(4) MANUFACTURED AND RELEASED ON 12-JAN-2023. EXPIRATION DATE: 2027-DEC-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.50.020 PEDICLE SCREW 6X55MM + NUT (1X) (K121115) LOT 2223938: (B)(4) MANUFACTURED AND RELEASED ON 08-JUN-2022. EXPIRATION DATE: 2027-MAY-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.50.019 PEDICLE SCREW 6X50MM + NUT (1X) (K121115) LOT 2458527: (B)(4) MANUFACTURED AND RELEASED ON 16-APR-2024. EXPIRATION DATE: 2029-MAR-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.50.019 PEDICLE SCREW 6X50MM + NUT (1X) (K121115) LOT 2459270: (B)(4) MANUFACTURED AND RELEASED ON 27-MAY-2024. EXPIRATION DATE: 2029-APR-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER THE COMPLAINT CONCERNS FRACTURE OF THE LEFT L5 PEDICLE SCREW APPROXIMATELY 14 MONTHS AFTER L2-L5 SPINAL STABILIZATION, WITH REPORTED MOBILIZATION OF THE L2 SCREWS. THE AVAILABLE X-RAY IMAGE CLEARLY CONFIRMS BREAKAGE OF THE LEFT L5 SCREW. IN ADDITION, A RADIOLUCENT AREA SUGGESTIVE OF BONE RESORPTION IS VISIBLE AROUND THE RIGHT L2 SCREW, COMPATIBLE WITH THE REPORTED SCREW LOOSENING. THE AVAILABLE FINDINGS ARE CONSISTENT WITH SPINAL HARDWARE FRACTURE, MOST LIKELY RELATED TO FATIGUE LOADING IN THE CONTEXT OF POSSIBLE PERSISTENT MOTION, DELAYED OR ABSENT FUSION, AND/OR INCREASED MECHANICAL DEMAND. THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. NO EVIDENCE CURRENTLY DEMONSTRATES A MANUFACTURING DEFECT. ROOT CAUSE:THE DEVICE BREAKAGE IS MOST LIKELY RELATED TO FATIGUE LOADING IN THE CONTEXT OF CASE-SPECIFIC CLINICAL AND MECHANICAL CONDITIONS, SUCH AS POSSIBLE PERSISTENT MOTION, DELAYED OR ABSENT FUSION, AND/OR INCREASED MECHANICAL DEMAND. WHILE THE EXACT ROOT CAUSE CANNOT BE DEFINITIVELY CONFIRMED, THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.