BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.U.S.T. MINI POLYAXIAL SCREW

    MDR report key: 22025605 · Received May 15, 2025

    Report

    Report Number
    3005180920-2025-00420
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    April 23, 2025
    Report Date
    July 8, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030863165
    PMA / PMN Number
    K171369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 APRIL 2025: LOT 2460768: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05/07/2024. EXPIRATION DATE: 11/06/2029. 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.

    Additional Manufacturer Narrative · 0

    FOLLOW UP 1: - DEVICE RETURNED TO MANUFACTUER ON 18-JUN-2025 - VISUAL INSPECTION VISUAL INSPECTION: BASED ON THE EVENT DESCRIPTION, IT WAS ASSUMED THAT THE PATIENT BONE CONDITION WAS NOT OPTIMAL DUE TO HARD BONE: BASICALLY, THIS CONDITION COULD POTENTIALLY INTRODUCE HIGHER RISK LIKE BONE OR IMPLANT FAILURE, IN PARTICULAR WHEN SCREWS ARE POSITIONED UNDER EXTREME TRAJECTORY AND/OR INTO REDUCED BONE SECTION. NO DEFECT CAN BE FOUND ON THE IMPLANT. THE EVENT WAS LIKELY CAUSED BY FACTORS THAT ARE INDEPENDENT FROM THE SCREW. CONCLUSION: 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

    C2-C7 FIXATION SURGERY. PATIENT'S PEDICLE BONE CRACKED AT C6 RIGHT SIDE WHILE INSERTING THE 3.5X14 PEDICLE SCREW (2.7 DIAMETER TAPPING PERFORMED). STRONG BONE. C6 LEVEL WAS SKIPPED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754916 M.U.S.T. MINI POLYAXIAL SCREW MUST MINI POLY.SCREW-FULL THREAD-3.5X14+NUT (STE) KWP MEDACTA INTERNATIONAL SA 03.75.002 2460768 07630030863165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other