BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM

    MDR report key: 11045698 · Received December 21, 2020

    Report

    Report Number
    11045698
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    October 21, 2020
    Report Date
    November 10, 2020
    Manufacturer
    AVALIGN TECHNOLOGIES, INC.
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A LUMBER FUSION SURGICAL PROCEDURE THE MICRO PITUITARY RONGEUR BROKE, A FRAGMENT BROKE OFF, SURGEON WAS ABLE TO RETRIEVE THE FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516891 MILLENNIUM RONGEUR, MANUAL HAE AVALIGN TECHNOLOGIES, INC. 9560565

    Patients

    Seq Age Sex Outcome Treatment
    1 20805 DA