BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMALL FIXATOR

    MDR report key: 35232 · Received July 18, 1996

    Report

    Report Number
    35232
    Event Type
    Other
    Date Received
    July 18, 1996
    Date of Event
    March 5, 1996
    Report Date
    March 8, 1996
    Manufacturer
    ELECTRO-BIOLOGY, INC.
    Product Code
    HTY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CHILD WITH FRACTURE OF RIGHT FEMUR. TO OR ON 3/5/96 FOR APPLICATION OF EXTERNAL FIXATOR DEVICE. DISPLACEMENT OF DEVICE NOTED. PT REQUIRED RETURN TO OR ON 3/7/96. DURING PRE-OP MANIPULATION OF 2ND DEVICE, 2ND DEVICE BROKE. THIRD DEVICE THEN PLACED IN PT, SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALL FIXATOR Implant FIXATOR, SMALL MODEL KIT HTY ELECTRO-BIOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other