BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLATO BPS

    MDR report key: 84096 · Received April 14, 1997

    Report

    Report Number
    1121753-1997-00008
    Event Type
    Other
    Date Received
    April 14, 1997
    Date of Event
    January 24, 1996
    Report Date
    April 11, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN INCORRECT RECONSTRUCTION IS POSSIBLE WHEN THE DIGITIZER IS USED AS THE IMPLANT RECONSTRUCTION METHOD. THE USER IS REQUESTED TO DIGITIZE TWO DIAGONAL CORNERS OF A RECTANGLE, THUS DEFINING AN AREA FROM WHICH THE RELEVANT ANATOMICAL AND IMPLANT INFO IS OBTAINED. DURING THE SETUP PROCEDURE, "ORIGIN" AND "POINT ON POS. X-AXIS" REQUIRE ENTRY TO POSITION THE FILM ON THE DIGITIZER. IF THESE PARAMETERS ARE NOT DEFINED, A WARNING MESSAGE IS GENERATED: "WARNING, CROSSWIRES NOT ORIENTED!" IF THE USER IGNORES THE WARNING AND PRESSES THE "OK" BUTTON, THE PROGRAM ALLOWS THE USER TO CONTINUE. THIS CAN RESULT IN AN INCORRECT RECONSTRUCTION OF THE IMPLANT IF THE CROSSWIRES ARE NOT ORIENTED TO THE CENTER OF THE AREA DEFINED BY THE DIAGONAL CORNERS OF A RECTANGLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATO BPS TREATMENT PLANNING SYSTEM IWB NUCLETRON CORP. PLATO-BPS V. 13.1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *