BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 2152422 · Received June 28, 2011

    Report

    Report Number
    1723170-2011-01164
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PART HAS BEEN RETURNED. MEDTRONIC REP EVALUATED SYSTEM AND COULD NOT REPLICATE ISSUE. MEDTRONIC REP STATED HE ADDED TOOL CARDS PRIOR TO SURGERY.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THE SYNERGY SPINE SOFTWARE WAS EXITING WHEN THE NAVLOCK INSTRUMENTS AND LEGACY 5.5 SCREW WHEN SELECTED. SHE REPORTED THAT THE TOOL CARD FOR THE SCREW WAS BLANK IN THE SOFTWARE APPLICATION. SITE WAS ABLE TO PROCEED IN THE SOFTWARE TO THE ACQUIRE SCAN TASK AND TAKE A SPIN WITH THE SYSTEM. NO IMPACT ON PT OUTCOME HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. I7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR