BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL NAVLOCK INSTRUMENT SET

    MDR report key: 5745217 · Received June 23, 2016

    Report

    Report Number
    1723170-2016-01213
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Date of Event
    May 27, 2016
    Report Date
    June 23, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POTENTIAL RISK ASSOCIATED WITH THE REPORTED INCIDENT WAS WITH THE USER, AND NOT THE PATIENT. THEREFORE, ESTIMATED DEMOGRAPHICS OF THE USER ARE PROVIDED. FIVE TRACKERS WERE RETURNED FOR EVALUATION WITH THE FOLLOWING LOT NUMBERS AND MANUFACTURE DATES: TRACKER 9734734 NAVLOCK UNIVERSAL GREEN (X2): 151023, 23OCT2015. TRACKER 9734683 NAVLOCK UNIVERSAL ORANGE (X2): 150928, 28SEP2015. TRACKER 9734590 NAVLOCK UNIVERSAL GREY (X1): 150929, 29SEP2015. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO INSPECT ALL THE NAVIGATED SPINE INSTRUMENTS. THE REP IDENTIFIED SOME FIT ISSUES AND RETURNED SEVERAL INSTRUMENTS TO THE MANUFACTURER FOR EVALUATION. THE RETURNED (B)(4) TRACKERS WERE FOUND TO BE IN GOOD CONDITION WITH NO APPARENT PHYSICAL DAMAGE. KNOWN GOOD INSTRUMENTS INSERTED, ROTATED AND RELEASED WITHOUT ISSUE. WITH MARKERS ATTACHED AND FULLY SEATED, THE TRACKERS RETURNED GOOD GEOMETRY AND DIVOT READINGS. THEY WERE ALL FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT TWO TAPS AND TWO DISC PREP INSTRUMENTS WERE GETTING STUCK ON THE GREEN, ORANGE, AND PURPLE TRACKERS. THEY TRIED INSTRUMENTS FROM ANOTHER TRAY AND THE INSTRUMENTS WERE STILL GETTING STUCK. THE SURGEON WAS USING THE INSTRUMENTS UNDER POWER. THERE WAS NO PATIENT OR USER IMPACT OR DELAY, THEY CONTINUED THE CASE WHILE THEY FOUND COMBINATIONS THAT WOULD WORK FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398758 UNIVERSAL NAVLOCK INSTRUMENT SET ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. (LOUISVILLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR