BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3890001 · Received April 25, 2014

    Report

    Report Number
    3890001
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 25, 2014
    Manufacturer
    SYNTHES LTD
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BROKEN SCREW FOUND ON X-RAY FOLLOWING AN OPEN REDUCTION LEFT HUMERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252589 * PLATE, FIXATION, BONE HRS SYNTHES LTD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR