BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION CEMENT GUN

    MDR report key: 1620947 · Received February 22, 2010

    Report

    Report Number
    1811755-2010-00169
    Event Type
    Malfunction
    Date Received
    February 22, 2010
    Date of Event
    January 22, 2010
    Report Date
    January 25, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    JDZ
    PMA / PMN Number
    K912190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED 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 THE CEMENT GUN CREATED METAL FILINGS WHEN COMPRESSED. NO FILINGS FELL INTO THE SURGICAL SITE. A BACK UP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO CLINICALLY RELEVANT DELAY. THERE ARE NO ALLEGATIONS OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION CEMENT GUN CEMENT MIXER FOR CLINICAL USE JDZ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK