BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALAUDRUCCIO

    MDR report key: 17316 · Received September 2, 1994

    Report

    Report Number
    17316
    Event Type
    Malfunction
    Date Received
    September 2, 1994
    Date of Event
    August 4, 1994
    Report Date
    August 29, 1994
    Manufacturer
    RICHARDS MEDICAL CO., INC.
    Product Code
    ITW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS 22-YR-OLD INITIALLY UNDERWENT A LEFT ANKLE FLEXOR AND ACHILLES LENGTHENING WITH POSTERIOR CAPSULOTOMY AND ANKLE ARTHRODESIS. A MEDIAL EXTERNAL FIXATION DEVICE WAS USED ON 8/1/94. WHILE THE PT WAS ON BEDREST AND STILL IN BED, THERE WAS A SPONTANEOUS BREAK OF THE EXTERNAL FIXATOR REQUIRING A RETURN OF THE PT TO THE OR FOR FAILED EXTERNAL FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALAUDRUCCIO Implant EXTERNAL FIXATOR FRAME ITW RICHARDS MEDICAL CO., INC. 11-1589

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other