BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 11814250 · Received May 12, 2021

    Report

    Report Number
    3006232063-2021-00011
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 12, 2021
    Manufacturer
    INTRINSIC THERAPEUTICS, INC.
    Product Code
    QES
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KNOWN INHERENT RISK OF DEVICE. THERE IS NO DEVICE ISSUE IDENTIFIED.

    Description of Event or Problem · 1

    PATIENT WAS ORIGINALLY IMPLANTED WITH BARRICAID FOLLOWING THE DISCECTOMY ON (B)(6) 2021. PATIENT HAD REHERNIATION AT THE IMPLANTED LEVEL OF L5-S1 AND ONE OTHER NON-IMPLANTED LEVEL ON (B)(6) 2021, DUE TO MULTIPLE REHERNIATIONS AT MULTIPLE LEVELS, SURGEON RECOMMENDED TLIF FUSION. REVISION SURGERY OCCURRED ON (B)(6) 2021, REMOVED BARRICAID IMPLANT AND PERFORMED A 2 LEVEL TLIF FUSION SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709941 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC. BAR-A8-8MM 07212001

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention