BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEK ARM II

    MDR report key: 2182242 · Received July 12, 2011

    Report

    Report Number
    1723170-2011-01228
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 10, 2011
    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

    ADD'L SERIAL #S: (B)(4). NO PT INFO PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. THE DEVICE MANUFACTURE DATES FOR THE THREE VERTEK ARMS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. RMA ISSUED. REPLACEMENT VERTEK ARMS SHIPPED ON (B)(4) 2011. RETURNED ITEMS WERE DISPOSITIONED AS SCRAP, RECEIVED BACK ON (B)(4) 2011.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE THREE OF THEIR VERTEK ARMS WERE NO LONGER ABLE TO BE TIGHTENED DOWN FULLY. THERE WAS NO PT PRESENT. SERIAL #(B)(4) - STARBURST END WILL NOT LOCK DOWN, SERIAL #(B)(4) - BOTH ENDS WILL NOT LOCK DOWN, SERIAL #(B)(4) - INSTRUMENT END WILL NOT LOCK DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEK ARM II STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1