BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVISIO NAVIGATION SYSTEM CALIBRATION DISK

    MDR report key: 21148850 · Received January 14, 2025

    Report

    Report Number
    21148850
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    January 8, 2025
    Report Date
    January 8, 2025
    Manufacturer
    ELUCENT MEDICAL, INC.
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SMART CLIP WOULD NOT CALIBRATE TO PATIENT. CALIBRATION DISK WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180039 ENVISIO NAVIGATION SYSTEM CALIBRATION DISK MARKER, RADIOGRAPHIC, IMPLANTABLE NEU ELUCENT MEDICAL, INC. NAV-SLIM 14909

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown