BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV 4.5MM TAP (CANNULATED)

    MDR report key: 3800674 · Received May 8, 2014

    Report

    Report Number
    1723170-2014-00461
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 9, 2014
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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, 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 04/09/2014. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR ANALYSIS.

    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 A NAVIGATED CANNULATED TAP INSTRUMENT THAT WAS CLOGGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279043 NAV 4.5MM TAP (CANNULATED) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1