MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM; PEDICLE SCREW 03.58.242 MUST MC SCREW Ø6X30 CANNULATED

Model Number	03.58.242
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 november 2024.Lot 2320589: (b)(4) items manufactured and released on 15-feb-2023.Expiration date: 2028-jan-26.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.Other device involved: batch review performed on 18 november 2024.Myspine 7.0725 myspine-mc drill guide l05 (k173472) lot 15309s: (b)(4) items manufactured and released on 04-nov-2024.Expiration date: 2025-apr-02.No anomalies found related to the problem.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.Visual inspection performed by r&d project manager no defect can be found on the implant.The event was likely caused by factors that are independent from the screw.The device analysis and the planning review performed by the mysolution department highlighted no issues in the case.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
The surgeon created the screw hole using the myspine mc guide.A crack in the bone occurred while inserting the pedicle screw (6mm x 05mm) at the right side of l5.The surgeon used another screw and changed the trajectory placing the screw freehand (6mm x 35mm).Bone quality normal.The hole was prepared by drilling, under tapping, and inline tapping, and then the screw was inserted.Due to this event, the surgery was extended to about 15 minutes (needed to prepare the new trajectory).The surgery lasted 4 hours.

• Brand Name: M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
• Common Device Name: PEDICLE SCREW 03.58.242 MUST MC SCREW Ø6X30 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: 20923087
• Report Number: 3005180920-2024-01048
• Device Sequence Number: 5055804
• Product Code: NKB
• UDI-Device Identifier: 07630971293540
• UDI-Public: 07630971293540
• 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): 12/13/2024

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: 03.58.242
• Device Lot Number: 2320589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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: Other
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian