BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNA MED

    MDR report key: 1732882 · Received June 21, 2010

    Report

    Report Number
    MW5016435
    Event Type
    Malfunction
    Date Received
    June 21, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 21, 2010
    Product Code
    ILZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DESIGN OF PRODUCT CHANGED A FEW YEARS AGO. PRODUCT IS ENGINEERED POORLY. ORDER FOR 7 PLACED, ON ARRIVAL 4 WERE OUT OF BOX DEFECTIVE. COMPANY REPLACED 4 AND UPON DELIVERY 3 WERE OUT OF BOX FAILURES. LOCKING MECHANISM FAILURES AND KICKSTAND AND MECHANICAL TRACTION. RED CLIPS FAIL CONSTANTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNA MED TRACTION SPLINT ILZ

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other