MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM; PEDICLE SCREW MUST MC SCREW Ø5.5X40 CANNULATED

Model Number	03.58.234
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Spinal fixation was performed at l4-l5 with myspine mc guide.When the surgeon tried to insert the pedicle screw (5.5mm x 40mm) at right side of l5, the patient bone broke.Patient's bone quality weak.Hole preparation: 5mm under tap 6mm same tap.The surgeon changed the trajectory and inserted the pedicle screw (5.5mm x 35mm).The reason for changing the screw length was that the trajectory was changed, resulting in a shorter trajectory.
Additional Manufacturer Narrative
Batch review performed on 31 march 2025 lot 2457685: (b)(4) items manufactured and released on 15-march-2024.Expiration date: 2029-02-24.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 does not present any problems.It has been implanted in a sawbone test.Root cause is not connected to the implant.Planning review performed by myspine team: our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.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: PEDICLE SCREW MUST MC SCREW Ø5.5X40 CANNULATED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21908585
• Report Number: 3005180920-2025-00310
• Device Sequence Number: 4059262
• Product Code: NKB
• UDI-Device Identifier: 07630971293465
• UDI-Public: 07630971293465
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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: 03.58.234
• Device Lot Number: 2457685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2024
• 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 Age: 83 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian