BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP

    MDR report key: 852788 · Received May 16, 2007

    Report

    Report Number
    1644408-2007-00053
    Event Type
    Malfunction
    Date Received
    May 16, 2007
    Date of Event
    April 6, 2007
    Report Date
    May 3, 2007
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWR
    PMA / PMN Number
    K041066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PORTION THAT BROKE OFF REMAINS IN PT. DEVICE NOT YET RECEIVED AT ENCORE. ADDITIONAL INFO WILL BE SENT WHEN AVAILABLE.

    Description of Event or Problem · 1

    RSP GLENOID BASEPLATE SCREW BROKE DURING INSERTION INTO THE PATIENT'S GLENOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP GLENOID BASEPLATE KWR ENCORE MEDICAL, L.P. 53829886

    Patients

    Seq Age Sex Outcome Treatment
    1 YR