MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM; MUST MC SCREW Ø7X45 CANNULATED

Model Number	03.58.265
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 jan 2026.Lot 2321452: (b)(4) items manufactured and released on 13-mar-2023.Expiration date: 2028-feb-19.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: the most plausible contributing factor is the lack of solid osseous fusion postoperatively, which may have resulted in implant loosening and/or increased mechanical loading on the screw under physiological conditions, potentially contributing to the observed loosening and screw breakage.While the exact root cause cannot be definitively confirmed, the investigation found no evidence of manufacturing defects or systemic issues related to the device.
Event or Problem Description
In (b)(6) 2023, plif (l3-l4) was performed for extension fixation of l4-l5 (plif).Must mc screw and competitor`s cage (mdm) were used.Presently, revision surgery was performed due to loosening and breakage of the left l4 screw.The broken screw was removed, the cage was reinserted, and the re-fixation (cement screw insertion, l2-l5) was performed.Patient`s bone quality reported to be weak.No traumatic event reported.

• Brand Name: M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
• Common Device Name: MUST MC SCREW Ø7X45 CANNULATED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24343886
• Report Number: 3005180920-2026-00103
• Device Sequence Number: 13272164
• Product Code: NKB
• UDI-Device Identifier: 07630971293779
• UDI-Public: 07630971293779
• Combination Product (Y/N): N
• PMA/510(K) Number: K210427
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 03.58.265
• Device Lot Number: 2321452
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian