BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDI PASSIVE SPHERES

    MDR report key: 5110264 · Received September 29, 2015

    Report

    Report Number
    3002743211-2015-00054
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 31, 2015
    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

    Additional Manufacturer Narrative · 1

    SPHERES WERE REPORTED TO HAVE AN UNEVEN REFLECTIVE SURFACE. THE SPHERES WHEN ROTATED WOULD RETURN LESS ERROR, HOWEVER, NOT ENOUGH FOR TRACKING TO OCCUR. IT IS NOT CLEAR IF THE UNEVEN REFLECTIVENESS OCCURED AS A RESULT OF THE SURGERY. DEVICE DISCARDED BY SITE.

    Description of Event or Problem · 1

    THIS EVENT WAS COMMUNICATED BY A MEDTRONIC (B)(4) REPRESENTATIVE FROM (B)(6)HOSPITAL. COMPLAINT WAS THAT THE SPHERES WERE NOT TRACKING. THEY REPLACED THE SPHERES AND WERE ABLE TO CONTINUE THE PROCEDURE. COMPLAINANT REPORTED THAT THERE WAS NO PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH. NO LOT NUMBER WAS RECORDED BY CUSTOMER. NO PICTURES WERE TAKEN BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642133 NDI PASSIVE SPHERES REFLECTIVE PASSIVE MARKER SPHERES HAW NORTHERN DIGITAL INC. 8801075

    Patients

    Seq Age Sex Outcome Treatment
    1