BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER AUTOPLEX CEMENT MIXER

    MDR report key: 18768515 · Received February 22, 2024

    Report

    Report Number
    MW5151878
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    February 16, 2024
    Report Date
    February 20, 2024
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    JDZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A KYPHOPLASTY, THE STRYKER AUTOPLEX CEMENT MIXER MADE AN ODD NOISE WHEN MIXING THE CEMENT AND MIXED APPROXIMATELY 30 SECONDS LONGER. THE VISCOSITY OF THE CEMENT WAS ACCEPTABLE AND WAS USED. SUBSEQUENTLY AN AVAFLEX NITINOL NEEDLE GOT STUCK IN THE CEMENT THAT WAS INJECTED FOR THE KYPHOPLASTY AND REQUIRED SURGICAL CUT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539017 STRYKER AUTOPLEX CEMENT MIXER MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention AVAFLEX CURVED NEEDLE