BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S7 NAVIGATION SYSTEM

    MDR report key: 8644400 · Received May 27, 2019

    Report

    Report Number
    1723170-2019-02681
    Event Type
    Malfunction
    Date Received
    May 27, 2019
    Date of Event
    July 26, 2017
    Report Date
    May 27, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PROBE HAS IMPACT MARKS AT THE BACK END CAUSING FIT ISSUES WITH THE MATING TRACKER. THE ISSUE WAS ABLE TO BE DUPLICATED. THERE IS NO 510K NUMBER AS PRODUCT IS NOT MARKETED IN THE US. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE LUMBAR PROBE WAS FOUND DEFORMED DURING THE PROCEDURE. THIS OCCURRED INTRA/PERI-OPERATIVELY WITH NO DELAY TO SURGICAL TIME. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437029 S7 NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9734056

    Patients

    Seq Age Sex Outcome Treatment
    1