BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCD PREC. SYS, 11G NEDL W/SPNPLX

    MDR report key: 1612040 · Received February 4, 2010

    Report

    Report Number
    2648666-2010-00056
    Event Type
    Malfunction
    Date Received
    February 4, 2010
    Date of Event
    January 7, 2010
    Report Date
    January 7, 2010
    Manufacturer
    STRYKER INSTRUMENT PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    K912190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY THE MFR FOR INVESTIGATION. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED. WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER MIXING THE CEMENT, PRIOR TO USE, SMALL PIECES OF GLASS WERE FOUND IN THE MIXING SECTION AND DELIVERY TUBE. THE CEMENT WAS NOT USED IN THE PROCEDURE. A BACK UP MIXER AND CEMENT WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO CLINICALLY RELEVANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCD PREC. SYS, 11G NEDL W/SPNPLX CEMENT MIXER FOR CLINICAL USE JDZ STRYKER INSTRUMENT PUERTO RICO 09261012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK