BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 11872112 · Received May 24, 2021

    Report

    Report Number
    3006232063-2021-00013
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    May 3, 2021
    Report Date
    May 24, 2021
    Manufacturer
    INTRINSIC THERAPEUTICS, INC.
    Product Code
    QES
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNINTENDED USE ERROR (E.G., LOSS OF HAND ANGLE CAUSING ERROR IN INPLANTATION).

    Description of Event or Problem · 1

    AFTER BEGINNING IMPLANTATION AT AN APPROPRIATE ANGLE, THE SURGEON ACCIDENTALLY MOVED HIS HAND THEREBY CHANGING THE IMPLANTATION ANGLE TO AN UNACCEPTABLE TRAJECTORY, RESULTING THE BARRICAID ANCHOR BEING IMPLANTED ACROSS THE DISC ENPLATE. THE IMPLANT HAS TO BE REMOVED, AND IT WAS REMOVED EASILY AND WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768885 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC. BAR-A8-8MM 12061901

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention