BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBALL HOOK

    MDR report key: 20311838 · Received September 25, 2024

    Report

    Report Number
    MW5160111
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    September 19, 2024
    Report Date
    September 19, 2024
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE HOOK, VERITY, NERVE, TI HANDLE, 2.0 MM BLUNT TIP, SS SHAFT, 7 1/4 IN, PART # 80-1532 MADE BY ASPEN SURGICAL BROKE OFF IN THE PATIENT DURING SPINAL SURGERY. IT IS THE 2ND HOOK TO BREAK WITHIN ONE WEEK. THE PIECE WAS RETRIEVED, SO THERE WAS NO PATIENT HARM, JUST A PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830879 MICROBALL HOOK HOOK, SURGICAL, GENERAL & PLASTIC SURGERY GDG ASPEN SURGICAL PRODUCTS, INC. 80-1532 932750

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female