BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 2012233 · Received February 2, 2011

    Report

    Report Number
    1723170-2011-00075
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    MEDTORNIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION NOT PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. DEVICE MANUFACTURE DATE NOT AVAILABLE AT TIME OF THIS REPORT. SOFTWARE INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THE SOFTWARE FROZE WHEN GOING INTO SYNERGY SPINE. THIS WAS BEING USED ON A STEALTHSTATION TRIA NAVIGATION SYSTEM. NO PT PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE