BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE STEALTH ISOC 3D PLUS

    MDR report key: 570095 · Received January 21, 2005

    Report

    Report Number
    1723170-2005-00001
    Event Type
    Malfunction
    Date Received
    January 21, 2005
    Date of Event
    December 17, 2004
    Report Date
    January 17, 2005
    Manufacturer
    MEDTRONIC SURGICAL NAVIGATION, INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SITE USING ISO-C, DID TWO SPINS, THEY BOTH WERE INACCURATE-THEY BOTH WERE OFF BY 3 CM SUPERIOR AND ANTERIOR. THE FIRST WAS DONE PRE-STERILE, THE SECOND WAS STERILE, AND THE ONLY DIFFERENCE WAS THAT ONE HAD THE FRAME WAS DRAPED. THE PT ENTERED THE SURGERY IN A PARAPLEGIC CONDITION-THE SURGEON REQUIRED USE OF STEALTH TO PROPERLY PLACE CERVICAL PINS. THE USE OF STEALTH AND CASE ABORTED. INVESTIGATION BY FIELD SERVICE MANAGER (FSM) INDICATES THAT ONE POSITION OF THE ISO-C WAS NOT CALIBRATED, WHICH WAS THE POSITION REQUIRED FOR THIS PARTICULAR CASE. ALL 8 POSITIONS ARE NOW CALIBRATED AND THE SYSTEM IS FULLY FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFACE STEALTH ISOC 3D PLUS C-ARM INTERFACE HAW MEDTRONIC SURGICAL NAVIGATION, INC. 9730889 2200403270001

    Patients

    Seq Age Sex Outcome Treatment
    1 *