M.U.S.T. POLYAXIAL PEDICLE SCREW

Description of Event or Problem

FEW DAYS AFTER THE PRIMARY LUMBAR FUSION WITH POSTERIOR SUPPLEMENTATION PERFORMED ON (B)(6) 2026, THE PATIENT DEVELOPED AN INFECTION. THE PATIENT RECEIVED TWO OTHER SURGERIES FOR SURGICAL CLEANING, ON (B)(6) 2026. NO DEVICES REVISED.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 07 JULY 2026 03.52.323 ENH. CANN. PEDICLE SCREW 6X40MM + NUT (1X) STERILE (K141988) LOT 2566405: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-DEC-2025. EXPIRATION DATE: 09-NOV-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.322 ENH. CANN. PEDICLE SCREW 6X35MM + NUT (1X) STERILE (K141988) LOT 1923102C: (B)(4) ITEM MANUFACTURED AND RELEASED ON 29-AUG-2025. EXPIRATION DATE: 28-JUL-2030. 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. 03.52.322 ENH. CANN. PEDICLE SCREW 6X35MM + NUT (1X) STERILE (K141988) LOT 2020513A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-AUG-2025. EXPIRATION DATE: 27-JUL-2030. 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. 03.52.426 ENH. BENT ROD TI R200 5.5X50MM - STERILE (K141988) LOT 2561862: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUL-2025. EXPIRATION DATE: 08-JUL-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.30.131 MECTALIF ANTERIOR CAGE - ENH SCREW DIAM.5X25 (2X) (K160605) LOT 2564903: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2025. EXPIRATION DATE: 21-SEP-2030. 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. 03.30.132 MECTALIF ANTERIOR CAGE - ENH SCREW DIAM.5X30 (2X) (K160605) LOT 2559770: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2025. EXPIRATION DATE: 25-MAR-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.33.027 MECTALIF ANTERIOR FLUSH MX TIPEEK 27X35X12 L15° (NOT REGISTERED IN US) LOT 2563914: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2025. EXPIRATION DATE: 05-OCT-2030. 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. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.