BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 1812906 · Received August 16, 2010

    Report

    Report Number
    9610726-2010-00258
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 6, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. 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

    IT WAS REPORTED THAT, "THE SIMPLEX SET SO QUICKLY IN THE SURGERY. (OPERATION ROOM TEMP 23 DEGREES IN C, TOTAL SETTING TIME 6 MINS, STORAGE LIFE, 1 MONTH (25 DEGREES IN C). THE SURGERY WAS COMPLETED WITHOUT ANY HEALTH CONSEQUENCES TO THE PT AND NO DELAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA JER018

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other