BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 251611 · Received November 24, 1999

    Report

    Report Number
    2242816-1999-00064
    Event Type
    Malfunction
    Date Received
    November 24, 1999
    Date of Event
    November 3, 1999
    Report Date
    November 23, 1999
    Manufacturer
    EBI MEDICAL SYSTEMS, INC.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FIXATOR WAS APPLIED FOR AN ELBOW FRACTURE. APPROXIMATELY TWO WEEKS LATER, THE PIVOT BODY WOULD NOT LOCK WHEN THE MD TRIED TO REPOSITION THE FIXATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX Implant EXTERNAL FIXATION HTY EBI MEDICAL SYSTEMS, INC. 01460 085100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other