BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TAPER TRIAL HEAD 36MM +2.5

    MDR report key: 2625731 · Received June 14, 2012

    Report

    Report Number
    2249697-2012-00748
    Event Type
    Malfunction
    Date Received
    June 14, 2012
    Date of Event
    May 22, 2012
    Report Date
    May 22, 2012
    Manufacturer
    STRYKER ORTHOAPEDICS MAHWAH
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT# 43KMED: DEVICE MANUFACTURE DATE: 3/16/2007. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME EVENT AS: MFR# 2249697-2012-00744, 00745, 00746, 00747, 00749.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE TRIAL HEADS LISTED SEEM TO HAVE DRIED BLOOD IN THE INTERNAL RINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TAPER TRIAL HEAD 36MM +2.5 INSTRUMENT KWA STRYKER ORTHOAPEDICS MAHWAH NA 6A0MMD & 43KMED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other