BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW MUST MC SCREW Ø5.5X45 CANNULATED

    MDR report key: 19536388 · Received June 14, 2024

    Report

    Report Number
    3005180920-2024-00403
    Event Type
    Injury
    Date Received
    June 14, 2024
    Date of Event
    May 15, 2024
    Report Date
    June 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971293472
    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 22 MAY 2024 LOT 2222497: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEPT-2022. EXPIRATION DATE: 2027-09-01. 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 MANAGER: NO DEFECT CAN BE SEEN ON THE SCREW. DIAMETER AND LENGTH ARE ACCORDING TO SPECIFICATION. THE ROOT CAUSE FOR THE FRACTURE OF THE PEDICLE CANNOT BE IMPUTED TO THE SCREW. PLANNING REVIEW: OUR ANALYSIS OF THE MYSPINE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY.

    Description of Event or Problem · 0

    DURING MYSPINE L4 SURGERY, WHILE THE SURGEON WAS TRYING TO INSERT THE MUST MC SCREW Ø5.5X45 CANNULATED, THE VERTEBRAL BODY CRACKED. TAPPING 5MM AND 6MM PERFORMED. THE SURGEON CHANGED THE ENTRY POINT, AND SUCCESSFULLY INSERTED THE SCREW (Ø5.5X35). PATIENT'S BONE QUALITY NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394769 PEDICLE SCREW MUST MC SCREW Ø5.5X45 CANNULATED SPINE MUST MC SCREW NKB MEDACTA INTERNATIONAL SA 2222497 07630971293472

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other