BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV THORACIC PROBE TIP

    MDR report key: 6191279 · Received December 20, 2016

    Report

    Report Number
    1723170-2016-05828
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    September 23, 2016
    Report Date
    December 20, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    OLO
    UDI-DI
    00613994870063
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE THORACIC PROBE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. TESTING FOUND THAT THE TIP OF THE PROBE WAS SEVERELY TWISTED AND THAT THE BACK END OF THE PROBE HAD IMPACT MARKS. THIS INDICATED A MECHANICAL FAILURE DUE TO A BENT INSTRUMENT TIP.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THAT THE TIP OF A THORACIC PROBE WAS BENT. THE SITE WAS ABLE TO SWITCH TO ANOTHER PROBE AND CONTINUE WITH THE PROCEDURE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841407 NAV THORACIC PROBE TIP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 150226 00613994870063

    Patients

    Seq Age Sex Outcome Treatment
    1