BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV LUMBAR PROBE TIP

    MDR report key: 4251555 · Received November 14, 2014

    Report

    Report Number
    1723170-2014-01232
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 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
    CO, 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

    MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE CONFIRMS THE TIP IS TWISTED AND BENT. THE REPORTED EVENT WAS CONFIRMED TO BE CAUSED BY THE PHYSICAL DAMAGE OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE THE LUMBAR PROBE INSTRUMENT WAS TWISTED WHILE BEING USED ON HARD BONE. 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
    738109 NAV LUMBAR PROBE TIP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 120702

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR