BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI DFS SMALL FIXATOR

    MDR report key: 42427 · Received October 14, 1996

    Report

    Report Number
    2242816-1996-00087
    Event Type
    Injury
    Date Received
    October 14, 1996
    Date of Event
    April 25, 1996
    Report Date
    October 14, 1996
    Manufacturer
    EBI MEDICAL SYSTEMS, INC
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MD APPLIED THE SMALL FIXATOR FOR A FEMORAL LENGTHENING. IT WAS SUBSEQUENTLY NOTED THAT THE SERRATED JOINTS ON THE FIXATOR HAD LOOSENED. A SECOND SURGERY WAS PERFORMED TO REPLACE THE FIXATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI DFS SMALL FIXATOR Implant EXTERNAL FIXATION HTY EBI MEDICAL SYSTEMS, INC 02000 005914

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention