BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDI PASSIVE SPHERES

    MDR report key: 4170574 · Received July 11, 2014

    Report

    Report Number
    3002743211-2014-00016
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 11, 2014
    Manufacturer
    NORTHERN DIGITAL, INC.
    Product Code
    HAW
    PMA / PMN Number
    K033621
    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 STERILE SPHERES WERE USED TO COMPLETE THE PROCEDURE. THIS ISSUE WAS COMMUNICATED BY MEDTRONIC NAVIGATION. SPHERES WERE NOT RETURNED AS THE DEVICE WAS USED IN A PROCEDURE AND CONSIDERED A BIOHAZARD. DECONTAMINATION OF SPHERE WOULD RENDER INVESTIGATION IMPOSSIBLE. SITE/USER DID NOT TAKE PICTURES OF SPHERE. THEREFORE, NO INVESTIGATION OR ANALYSIS COULD BE PERFORMED. CONTRACT MFR IS STILL EVALUATING DHR BASED ON LOT NUMBER FOR ANY QUALITY ISSUES. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PT WAS HARMED AND NO SERIOUS INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408523 NDI PASSIVE SPHERES REFLECTIVE PASSIVE MARKER SPHERES HAW NORTHERN DIGITAL, INC. 8801071 1309071

    Patients

    Seq Age Sex Outcome Treatment
    1