BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 2160118 · Received May 13, 2011

    Report

    Report Number
    1723170-2011-00968
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2010
    Manufacturer
    MEDTRONIC 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

    NO PT INFO PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. INVESTIGATION FINDS THAT AS REPORTED, ONE OF THE ATTACHMENT SCREWS HAS BEEN BROKEN OFF. RMA ISSUED. CONFIRMED WITH CUSTOMER SERVICE THAT IT WAS ORDERED (B)(4), ORDER NUMBER (B)(4). REPLACEMENT PART SENT.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED AN ATTACHMENT SCREW BROKE OFF THE REFERENCE FRAME. THERE IS NO INDICATION THAT THIS HAPPENED DURING A CASE. NO PT PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1