BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 17777063 · Received September 19, 2023

    Report

    Report Number
    3006232063-2023-00029
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 19, 2023
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    UDI-DI
    M906BARA88MM0
    PMA / PMN Number
    P160050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF INTRAOPERATIVE IMAGES REVEALED THAT THE OCCLUSION COMPONENT (MESH) WAS IMPACTING ON THE S1 BONE AND NOT GOING INTO THE DISC SPACE. THIS IMPACTION CAUSED THE OCCLUSION COMPONENT TO COMPRESS AND DETACH/TEAR FROM THE TITANIUM ANCHOR DURING IMPACTION/HAMMERING. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION ANOTHER FOLLOW-UP WILL BE COMPLETED. INTRINSIC THERAPEUTICS WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    DURING IMPLANTATION, THE OCCLUSION COMPONENT OF THE BARRICAID IMPLANT SEPARATED FROM THE TITANIUM ANCHOR. WHEN THE SURGEON REMOVED THE PUSHER ROD THE OCCLUSION COMPONENT CAME OUT WITH THE PUSHER ROD. THE TITANIUM ANCHOR WAS LEFT IMPLANTED, AND THE DISCECTOMY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938591 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 02272301 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention