BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.U.S.T. PEDICLE SCREW SYSTEM

    MDR report key: 23725621 · Received December 5, 2025

    Report

    Report Number
    3005180920-2025-01164
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    November 12, 2025
    Report Date
    December 5, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971278523
    PMA / PMN Number
    K203482
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2870625 M.U.S.T. PEDICLE SCREW SYSTEM MUST LT 15MM SHORT - PEDICLE SCREW Ø8X40 CANN NKB MEDACTA INTERNATIONAL SA 03.57.044 2560320 07630971278523

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other