BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSI MODULAR TABLE

    MDR report key: 1220704 · Received November 4, 2008

    Report

    Report Number
    MW5008860
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JFB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN PATIENT POSITIONED IN THE PRONE POSITION FOR LUMBER SPINE SURGERY, THE HIP PAD ATTACHED TO THE JACKSON TABLE FRAME BROKE. THE PAD REMAINED IN PLACE AND STABLE DURING THE SURGERY. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSI MODULAR TABLE JACKSON TABLE JFB ORTHOPEDIC SYSTEMS, INC. 5803

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR