MAUDE Adverse Event Report: Medacta International SA M.U.S.T. Midline Cortical (MC) Screw System; MUST MC Screw Ø7x35 cannulated

Model Number	03.58.263
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Spinal fixation was performed at l4-l5.The l5 pedicle fractured after the rod was inserted.The trajectory was changed from cbt to ps, and the same screw was reinserted.As the trajectory was altered, the required rod length changed, and a new rod (50 mm) was used.No critical delay.The quality of the patient`s bone was unknown.
Additional Manufacturer Narrative
Batch review performed on 20 aug 2026 lot 2228100: (b)(4) items manufactured and released on 09-dec-2022.Expiration date: 2027-nov-21.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: although no specific root cause can be confirmed, the issue experienced is likely related to the unique patient conditions and surgical application.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.

• Brand Name: M.U.S.T. Midline Cortical (MC) Screw System
• Common Device Name: MUST MC Screw Ø7x35 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: 50692269
• Report Number: 3005180920-2026-00887
• Device Sequence Number: 14934458
• Product Code: NKB
• UDI-Device Identifier: 07630971293755
• UDI-Public: 07630971293755
• Combination Product (Y/N): N
• PMA/510(K) Number: K210427
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 03.58.263
• Device Lot Number: 2228100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2022
• 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: Other
• Patient Sex: Unknown
• Patient Race: Asian