BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDI PASSIVE SPHERES

    MDR report key: 4346763 · Received December 3, 2014

    Report

    Report Number
    3002743211-2014-00048
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 13, 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

    STERILE SPHERE FAILED TO TRACK DURING A PROCEDURE. ANOTHER SET OF STERILE SPHERES WERE USED TO COMPLETE THE PROCEDURE. THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION. SITE/USER DISPOSED OF DEVICE, DID NOT RECORD LOT NUMBER AND DID NOT TAKE ANY PICTURES OF THE DEVICE. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PATIENT/USER OR OTHER SERIOUS HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779499 NDI PASSIVE SPHERES REFLECTIVE PASSIVE MARKER SPHERES, HAW, OLO HAW NORTHERN DIGITAL, INC. 8801075

    Patients

    Seq Age Sex Outcome Treatment
    1