BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT ACET WINDOW TRIAL 54MM

    MDR report key: 2885283 · Received November 21, 2012

    Report

    Report Number
    2249697-2012-02444
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED AS NO DEVICE WAS RECEIVED AND VALID LOT CODE WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WINDOW TRIAL IS PROBABLY 10 YEARS OLD. THE THREADS ARE GONE. NO DELAY TO SURGERY OR PATIENT. NEED NEW ONE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT ACET WINDOW TRIAL 54MM INSTUMENT LPH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK