BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM

    MDR report key: 7586219 · Received June 11, 2018

    Report

    Report Number
    7586219
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Date of Event
    May 3, 2018
    Report Date
    June 1, 2018
    Manufacturer
    AVALIGN TECHNOLOGIES, INC.
    Product Code
    HAE
    UDI-DI
    00190776104733
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SCREW FROM THE KERRISON #3 FELL OUT ON THE SURGICAL FIELD. THE SCREW AND THE TWO SEPARATE PORTIONS OF THE INSTRUMENT WERE REMOVED FROM THE SURGICAL FIELD AND AN X-RAY OF THE SURGICAL SITE WAS TAKEN AND READ AS CLEAR BY RADIOLOGIST PER POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429936 MILLENNIUM RONGEUR, MANUAL HAE AVALIGN TECHNOLOGIES, INC. 85-2481559 00190776104733

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT APPLICABLE.