BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVLOCK TRACKER UNIVERSAL ORANGE

    MDR report key: 3794006 · Received May 6, 2014

    Report

    Report Number
    1723170-2014-00451
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 10, 2014
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE AT TIME OF THIS REPORT. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE AT THIS TIME. RMA ISSUED. REPLACEMENT DEVICE SHIPPED TO SITE (B)(4) 2014. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR ANALYSIS. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    MFG DATE PROVIDED. THIS ISSUE WAS REVIEWED BY HARDWARE ENGINEERS. IT WAS FOUND THAT THE PART USED WITH THE MEDTRONIC NAVIGATION INC., TRACKER WAS NOT A MEDTRONIC PART. INSTRUCTIONS FOR USE DO NOT SUPPORT USE OF THIS PRODUCT WITH OTHER MANUFACTURER'S PRODUCTS.

    Additional Manufacturer Narrative · 1

    CORRECTION: ON 13-OCT-2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE, THE TRACKER INSTRUMENT BECAME STUCK IN A NUVASIVE DRIVER. THE SCREWDRIVER BECAME STUCK AND WOULD NO LONGER ROTATE; THEY WERE UNABLE TO DISENGAGE THE NAVLOCK TRACKER FROM THE NUVASIVE DRIVER. THE SURGEON USED A NUVASIVE NON-NAVIGATED DRIVER TO REMOVE THE SCREW AND THEN REPLACED IT WITH THE NUVASIVE NON-NAVIGATED DRIVER. THE MEDTRONIC REPRESENTATIVE INFORMED THE SURGEON THIS WAS AN OFF-LABEL USE OF THE NAVLOCK TRACKER INSTRUMENT. THE MEDTRONIC REPRESENTATIVE NOTED THAT THE SURGEON AND STAFF HAD BEEN CAUTIONED NUMEROUS TIMES OF THE RISK OF USING NUVASIVE WITH THE NAVLOCK TRACKER INSTRUMENT. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270283 NAVLOCK TRACKER UNIVERSAL ORANGE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 130114

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention