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

Model Number	03.58.634
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 oct 2025: lot 2463036: (b)(4) items manufactured and released on 24-oct-2024.Expiration date: 2029-oct-01.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.Visual inspection performed by r&d project manager: the screw is compliant.Root cause is not connected to the implant.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
Spinal fixation was scheduled to be performed at l3-l5.During the first step, the surgeon tried to insert the pedicle screw at l3, but the bone cracked.The fixation range was changed to l4-l5, only decompression was performed at l3.Note: the screw causing the bone fracture wasn't finally implanted.

• Brand Name: M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
• Common Device Name: PEDICLE SCREW MUST MC SCREW Ø5.5X40 REDUCTION CANN.
• 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: 23424431
• Report Number: 3005180920-2025-01005
• Device Sequence Number: 9854210
• Product Code: NKB
• UDI-Device Identifier: 07630971296060
• UDI-Public: 07630971296060
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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: 03.58.634
• Device Lot Number: 2463036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian