BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RV. UNIVERSAL CEMENT RESTRICTOR

    MDR report key: 1244483 · Received November 24, 2008

    Report

    Report Number
    2249697-2008-00373
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 30, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDK
    PMA / PMN Number
    K931847
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. DEVICE BROKEN, BLOODY AND DISCARDED, AND THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD DEVICE BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "CEMENT RESTRICTORS ARE BRITTLE AND STIFF AND WHEN PUT DOWN THE CANAL THEY BREAK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RV. UNIVERSAL CEMENT RESTRICTOR IMPLANT JDK STRYKER ORTHOPAEDICS MAHWAH NA 6M7496

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other