BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP

    MDR report key: 843581 · Received March 1, 2007

    Report

    Report Number
    1644408-2007-00016
    Event Type
    Malfunction
    Date Received
    March 1, 2007
    Date of Event
    February 1, 2007
    Report Date
    March 1, 2007
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWR
    PMA / PMN Number
    k041066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE RETAINING SCREW SNAPPED WHILE SCREWING DOWN THE GLENOSPHERE IN THE RSP. THE REMAINING PIECE WAS THREADED INTO THE BASEPLATE AND LEFT ONCE IT WAS DETERMINED THAT THE GLENOSPHERE WAS SECURED BY MORSE TAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP RETAINING SCREW KWR ENCORE MEDICAL, L.P. * 53813237

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 508, RSP GLENOID HEAD 36-4MM| 508, BASEPLATE