BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDI PASSIVE SPHERES

    MDR report key: 4184428 · Received October 16, 2014

    Report

    Report Number
    3002743211-2014-00039
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 19, 2014
    Manufacturer
    NORTHERN DIGITAL, INC.
    Product Code
    HAW
    PMA / PMN Number
    K033621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REFLECTIVE STERILE SPHERES FAILED TO TRACK DURING A PROCEDURE. ANOTHER SET OF SPHERES WERE USED TO COMPLETE THE PROCEDURE WITHOUT AN ISSUE. THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION. SITE/USER DISPOSED OF DEVICE AND DID NOT TAKE ANY PICTURES OF THE DEVICE. DHR WAS REVIEWED AND NO QUALITY ISSUES WERE NOTED. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PATIENT WAS HARMED AND NO SERIOUS INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656661 NDI PASSIVE SPHERES REFLECTIVE PASSIVE MARKER SPHERES, HAW,OLO HAW NORTHERN DIGITAL, INC. 8801085 1405311

    Patients

    Seq Age Sex Outcome Treatment
    1