BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL SIMPLEX CEMENT

    MDR report key: 1680918 · Received May 5, 2010

    Report

    Report Number
    9610726-2010-00140
    Event Type
    Malfunction
    Date Received
    May 5, 2010
    Date of Event
    March 9, 2010
    Report Date
    April 15, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. AND WAS CLEARED UNDER N17004.

    Description of Event or Problem · 1

    LIQUID BOTTLE IS BROKEN WHEN SURGEON OPEN THE SIMPLEXP BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL SIMPLEX CEMENT IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA CJQ124

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other