BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVLOCK UNIVERSAL GREEN TRACKER

    MDR report key: 5192855 · Received October 30, 2015

    Report

    Report Number
    1723170-2015-01318
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 2, 2015
    Report Date
    January 3, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. DEVICE LOT NUMBER NOT AVAILABLE. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER, THEREFORE, UNAVAILABLE. 510(K) DESIGNATION IS K050438. 10/12/2015 MEDTRONIC TECHNICAL SERVICES STATED THE SITE'S ISSUE WAS NOT WITH THEIR AWL, BUT WITH THEIR NAVLOCK TRACKER GREEN. RETURN REQUESTED FOR GREEN NAVLOCK TRACKER. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. NO FURTHER ISSUES HAVE BEEN REPORTED. PART NOT RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    CORRECTION: DEVICE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE LOT # AND MFG DATE NOW PROVIDED. ORIGINALLY THE SITE REPORTED THAT THE ISSUE WAS WITH THE TACTILE AWL AND WANTED TO REPLACE IT FOR FREE. HOWEVER, AFTER REVIEWING ALL THE CASES UNDER THIS SITE, IT WAS EVIDENT THAT THE SITE DOES NOT PROPERLY USE THE TACTILE AWL. IT WAS FOUND THAT THE ACTUAL ISSUE IS WITH THE GREEN NAVLOCK TRACKER. SINCE THEY WERE NOT RECEIVING A FREE REPLACEMENT (OUT OF 90 DAY WARRANTY), THEY DID NOT WANT TO REPLACE IT. THEREFORE, THE PART WILL NOT BE RETURNED OR REPLACED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, MATERIAL MANAGEMENT SUPERVISOR, REPORTED THAT THEY ARE UNABLE TO TIGHTEN THE SCREW ON THEIR TACTILE AWL. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721339 NAVLOCK UNIVERSAL GREEN TRACKER NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 110111

    Patients

    Seq Age Sex Outcome Treatment
    1