BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARAI HOLO PORTAL

    MDR report key: 15819126 · Received November 17, 2022

    Report

    Report Number
    3005725110-2022-00005
    Event Type
    Injury
    Date Received
    November 17, 2022
    Date of Event
    October 25, 2022
    Report Date
    November 17, 2022
    Manufacturer
    SURGALIGN SPINE TECHNOLOGIES
    Product Code
    LLZ
    PMA / PMN Number
    K211254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    RECEIVED INFORMATION THAT ALLEGED A COMBINATION OF PRODUCT MALFUNCTIONS MAY HAVE PROLONGED THE SURGICAL PROCEDURE BY 40 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2839009 ARAI HOLO PORTAL SYSTEM, IMAGE PRCESSING RADIOLOGICAL LLZ SURGALIGN SPINE TECHNOLOGIES 153000435

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other