BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVLOCK TRACKER UNIVERSAL ORANGE

    MDR report key: 5252009 · Received November 25, 2015

    Report

    Report Number
    1723170-2015-01462
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Date of Event
    October 30, 2015
    Report Date
    June 2, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CHANGING TO NAVLOCK TRACKER AS THE TRACKER IS THE INSTRUMENT THAT WAS REPLACED. THE INTERFACE BETWEEN THE TAP AND THE TRACKER CAUSED THE ISSUE.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER, THEREFORE, UNAVAILABLE. RETURN REQUESTED. REPLACEMENT SOLERA AWL TIP TAP 4.5MM TAP SHIPPED TO SITE (B)(6) 2015. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    CORRECTION: BRAND NAME & CATALOG NUMBER. DEVICE LOT NUMBER NOW PROVIDED. DEVICE MANUFACTURING DATE NOW PROVIDED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINT ALLEGES A SINGLE TRACKER WAS DAMAGED, 3 TOTAL TRACKERS WERE RETURNED FOR ANALYSIS: LOT# 100604 - MANUFACTURER DUE: 06/04/2010 AND 2 OF LOT # 150817 - MANUFACTURE DATE: 08/17/2015. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT TRACKER FINDS THAT THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE RETURNED TRACKERS WERE FOUND TO BE IN GOOD CONDITION WITH NO APPARENT PHYSICAL DAMAGE. KNOWN GOOD INSTRUMENTS INSERTED AND ROTATED WITHOUT ISSUE. WITH MARKERS ATTACHED AND FULLY, THE TRACKERS RETURNED GOOD GEOMETRY AND DIVOT ERROR READINGS. NO PROBLEM FOUND.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SITE'S SOLERA 4.5 AWL TIP TAP WAS DAMAGED. WHILE USING THE (B)(4) SYSTEM, THE TAP WAS WORKING SLOWLY THEN STOPPED SPINNING. THE TAP APPEARED TO BE STUCK ON THE TRACKER. THE SURGEON OPTED TO PROCEED WITH THE PROCEDURE WITH MANUAL TAPPING. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779218 NAVLOCK TRACKER UNIVERSAL ORANGE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 150817

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR