BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVLOCK TRACKER UNIVERSAL GREY

    MDR report key: 5313793 · Received December 21, 2015

    Report

    Report Number
    1723170-2015-01573
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Date of Event
    November 23, 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
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. DEVICE LOT NUMBER NOT AVAILABLE. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER, THEREFORE, UNAVAILABLE. RETURN REQUESTED. REPLACEMENT DEVICE SHIPPED TO SITE 12/11/2015. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    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# 100521- MANUFACTURER DUE: 05/21/2010 AND 2 OF LOT # 150814 - MANUFACTURE DATE: 08/14/2015. 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 A SITE'S GRAY NAVLOCK TRACKER WAS DAMAGED. WHILE USING THE NON-MEDTRONIC POWEREASE SYSTEM, THE TRACKER AND THE TAP BECAME JAMMED TOGETHER. THE TAP APPEARED TO BE STUCK ON THE TRACKER. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839954 NAVLOCK TRACKER UNIVERSAL GREY ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 150814

    Patients

    Seq Age Sex Outcome Treatment
    1