BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2050115 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00564
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 31, 2010
    Report Date
    March 31, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPUTER WAS REPLACED AND THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    SITE REPORTED SYNERGY SPINE 1.7 APPLICATION FREEZES SPORADICALLY AND IN FLUORO PROCEDURE, ALL INSTRUMENTS ARE SHOWN IN GREY INSTEAD OF IN THE APPROVED COLORS. NO IMPACT ON PT OUTCOME WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1