BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S3 PROXIMAL HUMERUS PLATING

    MDR report key: 2051693 · Received April 6, 2011

    Report

    Report Number
    2051693
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Manufacturer
    DEPUY
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SCREW WAS LOOSE AND WAS REMOVED. MECHANICAL FAILURE.======================MANUFACTURER RESPONSE FOR LOCKING SMOOTH PEG======================MANUFACTURER REPRESENTATIVE IS AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S3 PROXIMAL HUMERUS PLATING LOCKING SMOOTH PEG KWS DEPUY STP-45 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR