M.U.S.T. MINI POLYAXIAL SCREW

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 23 JUNE 2026: LOT 2657516: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 MARCH 2026. EXPIRATION DATE: 29-JAN-2031. 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. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED FOR THE REPORTED VERTEBRAL ARCH FRACTURE. THE AVAILABLE CLINICAL INFORMATION DOES NOT INDICATE THAT ANY POTENTIAL DEVICE-RELATED ISSUE CAUSED OR CONTRIBUTED TO THE EVENT. THE BATCH REVIEW PERFORMED DID NOT IDENTIFY ANY POTENTIALLY RELATED MANUFACTURING ANOMALY, AND NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THE SAME LOT DURING THE PERIOD OF REVIEW.

Description of Event or Problem

DURING PEDICLE SCREW INSERTION (OPERATED LEVEL C3-C7), A FRACTURE OCCURRED AT THE VERTEBRAL ARCH, NOT IN THE VERTEBRA ITSELF. THE SURGERY WAS COMPLETED WITHOUT INSERTING THE PEDICLE SCREW INTO THE FRACTURED LEVEL. DUE TO THE EVENT, THE SURGERY WAS PROLONGED BY APPROXIMATELY 5 MINUTES, WITH A TOTAL SURGICAL TIME OF ABOUT 4 HOURS. NO DIFFERENT TREATMENT TO HEAL THE FRACTURE IS KNOWN AT THIS TIME. POST-OPERATIVE X-RAYS ARE NOT AVAILABLE. IT IS CURRENTLY UNKNOWN WHETHER THE MISSING SCREW AND THE FRACTURE COULD LEAD TO REVISION SURGERY. NO SURGEON COMMENTS WERE PROVIDED.