BEUDAMED
    FDA Adverse Event Other Summary report: N

    WILSON PLUS RADIOLUCENT WILSON FRAME

    MDR report key: 617096 · Received June 13, 2005

    Report

    Report Number
    617096
    Event Type
    Other
    Date Received
    June 13, 2005
    Date of Event
    March 30, 2005
    Report Date
    June 13, 2005
    Manufacturer
    ORTHOPEDIC SYSTEMS, INC.
    Product Code
    FWZ
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WEIGHT EXCEEDED WEIGHT LIMIT FOR WILSON FRAME. THE SURGEON REQUESTED TO CONTINUE USING FRAME WHEN NOTIFIED OF LIMIT PRIOR TO SURGERY WITH EXTRA PADDING. NO PROBLEM WITH FRAME DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILSON PLUS RADIOLUCENT WILSON FRAME SURGICAL TABLE FWZ ORTHOPEDIC SYSTEMS, INC. WILSON PLUS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR