BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV LUMBAR PROBE TIP

    MDR report key: 3821445 · Received May 20, 2014

    Report

    Report Number
    1723170-2014-00583
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 22, 2014
    Report Date
    November 9, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    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

    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.

    Additional Manufacturer Narrative · 1

    RMA ISSUED. REPLACEMENT LUMBAR PROBE SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THAT, AS REPORTED, THE TIP OF THE INSTRUMENT HAS BEEN TWISTED. THERE ARE IMPACT MARKS AT THE BACK END OF THE INSTRUMENT. MECHANICAL FAILURE, BENT INSTRUMENT TIP, DIRECTLY CAUSED EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SITE DAMAGED A LUMBAR PROBE. THE TIP OF THE INSTRUMENT WAS BENT DURING A L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE. 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
    300511 NAV LUMBAR PROBE TIP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 121022

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR