BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV THORACIC PROBE TIP

    MDR report key: 9371954 · Received November 25, 2019

    Report

    Report Number
    1723170-2019-05773
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    November 6, 2019
    Report Date
    February 5, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    UDI-DI
    00763000054205
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. INITIAL REPORTER UNKNOWN AT THE TIME OF THIS REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE THORACIC PROBE 9734680 NAVLOCK (LOT# 190516) WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND THAT THE RETURNED PROBE HAD SEVERAL IMPACT MARKS AT THE BACK END CAUSING THE REPORTED FIT ISSUES WITH THE MATING TRACKER. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND REPORTER SECTION HAS BEEN UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION DEVICES USED FOR SACROILIAC AND THORACOLUMBAR PROCEDURES. IT WAS REPORTED THAT THREE PROBES WERE ALL DAMAGED IN THE SAME SPOT. IT WAS NOTED THAT THE CLINICAL DETAILS OF THE CASES WERE UNKNOWN BY THE SITE AND THAT THE SITE USED A MALLET ON THE INSTRUMENTS. THERE WAS A LESS THAN HOUR SURGICAL DELAY AND NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165037 NAV THORACIC PROBE TIP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9734680 190516 00763000054205

    Patients

    Seq Age Sex Outcome Treatment
    1