BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1932147 · Received December 14, 2010

    Report

    Report Number
    1723170-2010-00174
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    MEDTORNIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE REPORTED EVENT, THE INACCURACY DURING NAVIGATION WAS DUE TO REFERENCE FRAME MOVEMENT BY THE OPERATOR, AND NOT A MALFUNCTION OF THE DEVICE. THE SYSTEM BEHAVED AS DESIGNED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN ALLEGED INACCURACY AFTER COMPLETING NAVIGATED 3D SPIN IN A SPINE SURGERY. THE INACCURACY WAS THOUGHT TO HAVE BEEN CAUSED BY FRAME MOVEMENT. THEY TOOK ANOTHER 3D SPIN AND WERE ACCURATE. THE SURGEON COMPLETED THE SURGERY USING THE SYSTEM WITH NO IMPACT TO THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTORNIC NAVIGATION, INC. TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR