M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
Received Jul 21, 2026 · Event occurred Jul 7, 2026
Report 3005180920-2026-00760 · MDR key 25886769
Device
Generic name
Must Mc Screw Ø6x35
Manufacturer
Medacta International SaModel number
03.58.443Lot number
2327419
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
51 YR · Female
- Inflammation
Narrative
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON 20 JULY 2026 LOT. 2327419: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2023. EXPIRATION DATE: 12-NOV-2028. 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, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.
Description of Event or Problem
REVISION SURGERY DUE TO IRRITATIONAT THE L5 SITE AND THE CAUSE IS UNKNOWNAFTER 7 DAYS FROM PRIMARY. THE SURGEON REVISED THE MUST MC SCREW D 6X35 AND IMPLANTED A MUST MC SCREW D 7X25.