BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI DFS DISTAL RADIUS FIXATOR

    MDR report key: 45284 · Received October 25, 1996

    Report

    Report Number
    2242816-1996-00094
    Event Type
    Malfunction
    Date Received
    October 25, 1996
    Date of Event
    July 1, 1996
    Report Date
    October 24, 1996
    Manufacturer
    EBI MEDICAL SYSTEMS, INC.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MD APPLIED THE FIXATOR TO TREAT A DISTAL RADIUS FRACUTRE. THE PT SUBSEQUENTLY RETURNED TO THE MD'S OFFICE BECAUSE THE BALL JOINT HAD LOOSENED. THE MD WAS ABLE TO RETIGHTEN THE BALL JOINT IN HIS OFFICE. THERE WAS NO INJURY TO THE PT.

    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 004649

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other