BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

    MDR report key: 20923087 · Received December 13, 2024

    Report

    Report Number
    3005180920-2024-01048
    Event Type
    Injury
    Date Received
    December 13, 2024
    Date of Event
    November 15, 2024
    Report Date
    December 13, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971293540
    PMA / PMN Number
    K210427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2416503 M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM PEDICLE SCREW 03.58.242 MUST MC SCREW Ø6X30 CANNULATED NKB MEDACTA INTERNATIONAL SA 03.58.242 2320589 07630971293540

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Other