MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. PEDICLE SCREW SYSTEM; MUST LT 15MM SHORT - PEDICLE SCREW Ø8X40 CANN

Model Number	03.57.044
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 november 2025.Lot 2560320: (b)(4) items manufactured and released on 07-may-2025.Expiration date: 2030-04-16.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.Visual inspection: the screw is compliant, a sawbone test has been completed withouth issues.Root cause is not connected to the implant.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.
Event or Problem Description
When the surgeon tried to insert the pedicle screw (8mm x 40 mm) at right side of l5, the patient's pedicle broke.The patient's bones were osteosclerotic.Back-up used (8mm x 50mm).

• Brand Name: M.U.S.T. PEDICLE SCREW SYSTEM
• Common Device Name: MUST LT 15MM SHORT - PEDICLE SCREW Ø8X40 CANN
• 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: 23725621
• Report Number: 3005180920-2025-01164
• Device Sequence Number: 13430320
• Product Code: NKB
• UDI-Device Identifier: 07630971278523
• UDI-Public: 07630971278523
• Combination Product (Y/N): N
• PMA/510(K) Number: K203482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/05/2025

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: 03.57.044
• Device Lot Number: 2560320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian