BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 15871757 · Received November 28, 2022

    Report

    Report Number
    3006232063-2022-00009
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    March 28, 2022
    Report Date
    November 28, 2022
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    UDI-DI
    M906BARA810MM0
    PMA / PMN Number
    P160050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE SURGEON NARRATIVE, IMAGING, AND RETURNED DELIVERY INSTRUMENT, IT WAS CONFIRMED THAT MESH GUIDE DETACHMENT HAD OCCURRED DURING IMPLANTATION. NO DEVIATIONS OR NON-CONFORMANCES WERE NOTED IN THE LOT HISTORY REVIEW. THE FLUOROGRAPHS PROVIDED EVIDENCE THAT THE ROOT CAUSE WAS RELATED TO SUB-OPTIMAL POSITIONING OF THE DELIVERY SHEATH SUCH THAT THE POLYMER BARRIER WAS BEING IMPLANTED DIRECTLY INTO BONE. THE SUB-OPTIMAL POSITIONING MAY HAVE BEEN RELATED TO UNUSUALLY HIGH HARDNESS OF THIS S1 VERTEBRAL BODY.

    Description of Event or Problem · 0

    A BARRICAID IMPLANTATION WAS ATTEMPTED THROUGH A 4MM TALL BY 8MM WIDE DEFECT IN L5/S1. THE SURGEON CHOSE TO IMPLANT INTO THE S1 VERTEBRAL BODY AND NOTED THAT THE BONE WAS HARDER THAN WHAT HE TYPICALLY HAS ENCOUNTERED. DURING IMPLANTATION, THE NITINOL MESH GUIDE FRACTURED, AND THE IMPLANT WAS REMOVED. A SECOND IMPLANT ATTEMPT WAS MADE AND WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2663775 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-10MM 06152002 M906BARA810MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Unknown Required Intervention