BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACK BELT ADVANCED CERVICAL RETRACTOR SYSTEM

    MDR report key: 20952016 · Received December 17, 2024

    Report

    Report Number
    20952016
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 19, 2024
    Report Date
    December 4, 2024
    Manufacturer
    KOROS USA, INC.
    Product Code
    GZT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING A LUMBAR LAMINECTOMY, THE BLACKBELT RETRACTOR WAS USED. ON REMOVAL OF THE RETRACTOR, THE PHYSICIAN SAW THE SCREW FALL OUT ONTO THE DRAPE AND RETRIEVED IT. TO BE SURE NO ITEMS FROM THE RETRACTOR WERE RETAINED IN THE PATIENT, X-RAYS WERE PERFORMED AND NO FOREIGN BODY WERE SEEN. THE RETRACTOR WAS SENT TO CENTRAL STERILE PROCESSING DEPARTMENT FOR CLEANING AND TO BE SENT OUT FOR REPAIR. NO OTHER RETRACTOR WAS NEEDED DURING THE CASE. THIS OCCURRED AT THE END OF THE CASE, NO DELAY AS RADIOLOGY WAS PRESENT IN THE OPERATING ROOM FOR THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239716 BLACK BELT ADVANCED CERVICAL RETRACTOR SYSTEM RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY GZT KOROS USA, INC. 7320

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown