BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL SHARP 9734678 NAVLOCK

    MDR report key: 8721543 · Received June 21, 2019

    Report

    Report Number
    1723170-2019-03712
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    January 26, 2018
    Report Date
    June 21, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION INSTRUMENTS BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS DEFORMATION OF THE AWL TIP THE TRACKER COULD NOT BE ATTACHED TO IT. THE EVENT WAS COMPLETED USING THE NAVIGATION SYSTEM. THERE WAS NO DELAY AND NO IMPACT ON THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514650 AWL SHARP 9734678 NAVLOCK ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9734678 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1