BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL RADIOULNAR JOINT PLATE ASSEMBLY

    MDR report key: 2518310 · Received February 18, 2009

    Report

    Report Number
    3004521401-2009-00001
    Event Type
    Injury
    Date Received
    February 18, 2009
    Date of Event
    December 19, 2008
    Report Date
    February 13, 2009
    Manufacturer
    APTIS MEDICAL, LLC.
    Product Code
    KXE
    PMA / PMN Number
    K040497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TWO SMALL RADIAL PLATE COVER SCREWS BACKED OUT OF THEIR ASSEMBLED POSITION ALLOWING THE RADIAL PLATE COVER TO COME FREE FROM THE RADIAL PLATE. THE DEVICE WAS RETURNED AND FOUND TO HAVE NO VISUAL DEFECTS. THE DEVICE WAS REASSEMBLED, ALL PARTS MATED PROPERLY AND FUNCTIONED AS DESIGNED. FACTORS DURING THE PROCEDURE SUCH AS SCREWS NOT SUFFICIENTLY TIGHTENED AND/OR ANATOMY INTERPOSED BETWEEN THE MATING SURFACES OF THE DEVICE COULD HAVE LED TO LOOSENING OF THE SCREWS. BASED ON THE SUCCESSFUL FUNCTIONAL TEST RESULTS AND DISCUSSIONS WITH THE OPERATOR, THE CAUSE OF THIS OCCURRENCE IS LIKELY INADEQUATE TIGHTENING OF THE RADIAL COVER SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTAL RADIOULNAR JOINT PLATE ASSEMBLY KXE APTIS MEDICAL, LLC. DRUJ-P20 K10831

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R