BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 15052327 · Received July 19, 2022

    Report

    Report Number
    3006232063-2022-00006
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Date of Event
    March 10, 2022
    Report Date
    July 18, 2022
    Manufacturer
    INTRINSIC THERAPEUTICS, INC.
    Product Code
    QES
    UDI-DI
    M906BARA88MM0
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BARRICAID MESH GUIDE NITINOL WIRE BROKE DURING IMPLANTATION. THE REMOVAL TOOL WAS USED TO REMOVE THE INCOMPLETE IMPLANTATION. ALL COMPONENTS WERE ACCOUNTED FOR AND THERE WAS NO PATIENT INJURY. ANOTHER BARRICAID IMPLANT WAS INSERTED IN THE SAME VERTEBRAL BODY WITH NO ADDITIONAL ISSUE. ALL ACTIVITIES WERE PERFORMED DURING THE IMPLANTATION (B)(6) 2022 WITH ONLY A 3 MINUTE DELAY TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262403 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC. BAR-A8-8MM 08162101 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Prefer Not To Disclose Required Intervention