BEUDAMED
    FDA Adverse Event Other Summary report: N

    WILSON FRAME

    MDR report key: 1714351 · Received May 21, 2010

    Report

    Report Number
    2921578-2010-00008
    Event Type
    Other
    Date Received
    May 21, 2010
    Date of Event
    March 12, 2010
    Report Date
    May 20, 2010
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE WILL CONTACT CUSTOMER TO SEE IF FAILED COMPONENT CAN BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    PT WAS PROLINED ON WILSON FRAME FOR A LAMINECTOMY DECOMPRESSION. WHEN THE RN STARTED TO MANUALLY CRANK THE PT INTO POSITION, THE ENTIRE PLASTIC BOTTOM CRACKED ACROSS THE ENTIRE WIDTH. (B)(6); THE MAXIMUM FRAME'S WEIGHT IS 250 LBS. NO HARM TO PT AND THE SURGERY WAS COMPLETED WITHOUT HAVING TO REMOVE PT FROM FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILSON FRAME OPERATING ROOM TABLE, ACCESSORY JEB MIZUHO ORTHOPEDIC SYSTEMS, INC. 5319G

    Patients

    Seq Age Sex Outcome Treatment
    1