BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 12036723 · Received June 21, 2021

    Report

    Report Number
    3006232063-2021-00015
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 21, 2021
    Manufacturer
    INTRINSIC THERAPEUTICS, INC.
    Product Code
    QES
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KNOWN INHERENT RISK OF DEVICE (REHERNIATION CAN STILL OCCUR WITH USE OF DEVICE).

    Description of Event or Problem · 1

    PATIENT REHERNIATED. SURGEON DECIDED TO PERFORM TLIF. SURGEON REMOVED THE OCCLUSION COMPONENT OF BARRICAID IN ORDER TO MAKE ROOM FOR THE TLIF. BARRICAID IMPLANT WAS OBSERVED TO BE INTACT UPON EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929870 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC. BAR-A8-8MM 06112001

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention