BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDI PASSIVE SPHERES

    MDR report key: 4888593 · Received July 2, 2015

    Report

    Report Number
    3002743211-2015-00036
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 4, 2015
    Manufacturer
    NORTHERN DIGITAL INC.
    Product Code
    HAW
    PMA / PMN Number
    K033621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUALIZATION OF THE DEVICE INDICATES NON-REFLECTIVE AREAS ON THE SPHERE. THE NON-REFLECTIVE SURFACE IS QUITE SMALL COMPARED TO THE OVERALL REFLECTIVENESS OF THE SPHERE. THE ORIGIN/CAUSE OF THE NON-FLECTIVE PORTIONS IS EITHER A MANUFACTURING DEFECT OR CAME ABOUT DURING HANDLING OF THE SPHERE BY THE USER.

    Description of Event or Problem · 1

    THIS EVENT WAS COMMUNICATED BY A CUSTOMER REPRESENTATIVE WHO REPORTED THAT A SITE ((B)(6)) HAD SPHERES THAT DID NOT TRACK. SITE REPLACED SPHERES AND THE NEW SPHERES WERE ABLE TO TRACK. COMPLAINANT REPORTED THAT THERE WAS NO PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431364 NDI PASSIVE SPHERES REFLECTIVE PASSIVE MARKER SPHERES HAW NORTHERN DIGITAL INC. 8801002

    Patients

    Seq Age Sex Outcome Treatment
    1