M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 01 JULY 2026 PEDICLE SCREW 03.58.223 MUST MC SCREW D 5X35 CANNULATED (K210427) LOT. 2328478: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2024. EXPIRATION DATE: 2028-11-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW.

Description of Event or Problem

TLIF SURGERY WAS PERFORMED AT L3-L4. WHEN THE PEDICLE SCREW (5MM X 35MM) WAS INSERTED AT RIGHT SIDE OF L4, THE BONE FRACTURE OCCURED. THE SURGEON CHANGED THE TRAJECTORY , AND REPLACED WITH THE PEDICLE SCREW (6MM X 40MM). PATIENT`S POOR BONE QUALITY.