BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC STEREOTAXIC INSTRUMENT

    MDR report key: 8487310 · Received April 5, 2019

    Report

    Report Number
    1723170-2019-01558
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    April 1, 2019
    Report Date
    September 3, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    UDI-DI
    00763000053994
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE AWL 9734404 TIP (LOT# 180517) WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND THAT THE RETURNED AWL HAD 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE AWL TIP JAMMED ON THE HAND GRIP. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280683 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9734404 180517 00763000053994

    Patients

    Seq Age Sex Outcome Treatment
    1