BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER 9735024 SOLERA 5.5/6.0 MAS CANN

    MDR report key: 9256485 · Received October 30, 2019

    Report

    Report Number
    1723170-2019-05405
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    October 9, 2019
    Report Date
    October 30, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. THE DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN (LOT# 170527) WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND THAT THE TIP OF THE DRIVER HAD BEEN BROKEN OFF. 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. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT A CANNULATED DRIVER WAS FOUND TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048781 DRIVER 9735024 SOLERA 5.5/6.0 MAS CANN ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9735024 170527

    Patients

    Seq Age Sex Outcome Treatment
    1