BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 16138890 · Received January 11, 2023

    Report

    Report Number
    3006232063-2022-00052
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 13, 2022
    Report Date
    January 11, 2023
    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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGEON'S INITIAL ATTEMPT TO IMPLANT A BARRICAID DEVICE WAS INTO S1, AFTER STRIKING THE STRIKE CAP BEGAN TO BOUNCE THEN THE GUIDEWIRE BROKE. DEVICE WAS REMOVED USING REMOVAL TOOL AND A SECOND IMPLANT ATTEMPT WAS SUCCESSFUL ON THE OPPOSING VERTEBRAL BODY (L5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908967 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 04182201 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Unknown Other