BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI DFS STANDARD FIXATOR

    MDR report key: 44663 · Received October 14, 1996

    Report

    Report Number
    2242816-1996-00089
    Event Type
    Malfunction
    Date Received
    October 14, 1996
    Date of Event
    April 1, 1996
    Report Date
    October 14, 1996
    Manufacturer
    EBI MEDICAL SYSTEMS, INC
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUBSEQUENT TO THE FIXATOR BEING APPLIED IT WAS NOTED THAT ONE OF THE CLAMPS HAD BROKEN. THE FIXATOR WAS REMOVED AND A NEW FIXATOR APPLIED. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI DFS STANDARD FIXATOR Implant EXTERNAL FIXATION HTY EBI MEDICAL SYSTEMS, INC 01001 4236

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other