BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED CEMENT MIXING BOWL AN

    MDR report key: 953857 · Received November 20, 2007

    Report

    Report Number
    2648666-2007-00079
    Event Type
    Malfunction
    Date Received
    November 20, 2007
    Date of Event
    October 19, 2007
    Report Date
    October 25, 2007
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    K912190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PLASTIC RIDGE ON THE CARTRIDGE BROKE OFF. AS A RESULT, THE CARTRIDGE DISLODGED FROM THE GUN, WHEN THE CEMENT WAS INJECTED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED CEMENT MIXING BOWL AN CEMENT MIXER JDZ STRYKER INSTRUMENTS PUERTO RICO 07206012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR