BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER 11G 15MM FRACTURE KIT

    MDR report key: 19499685 · Received June 7, 2024

    Report

    Report Number
    MW5155997
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    June 4, 2024
    Report Date
    June 5, 2024
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STRYKER 11G 15MM FRACTURE KIT MALFUNCTIONED (SPLIT LENGTHWISE) DURING A KYPHOPLASTY PROCEDURE. REFERENCE: 1032-115-000, LOT: 9512935, EXP.: 12/13/2024. DEVICE OFFER TO STRYKER REP AT TIME OF FAILURE, IMAGES OBTAINED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184245 STRYKER 11G 15MM FRACTURE KIT ARTHROSCOPE HRX STRYKER INSTRUMENTS 9512935

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female