BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI DFS DISTAL RADIUS FIXATOR

    MDR report key: 44933 · Received October 22, 1996

    Report

    Report Number
    2242816-1996-00088
    Event Type
    Injury
    Date Received
    October 22, 1996
    Date of Event
    March 23, 1996
    Report Date
    October 21, 1996
    Manufacturer
    EBI MEDICAL SYSTEMS, INC.
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE FIXATOR WAS APPLIED TO TREAT A DISTAL RADIUS FRACTURE. APPROX. EIGHT DAYS AFTER APPLICATION, IT WAS NOTED THAT THE DISTAL BALL JOINT HAD LOOSENED RESULTING IN A LOSS OF FRACTURE ALIGNMENT. THE MD PERFORMED A SECOND SURGERY TO REALIGN THE FRACTURE AND REAPPLY THE FIXATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI DFS DISTAL RADIUS FIXATOR Implant EXTERNAL FIXATION HTY EBI MEDICAL SYSTEMS, INC. 04003 005299

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention