BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 20125349 · Received September 3, 2024

    Report

    Report Number
    3006232063-2024-00034
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 8, 2024
    Report Date
    September 3, 2024
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    UDI-DI
    M906BARA88MM0
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF AVAILABLE IMAGING SUGGESTS THAT THE DEVICE CAUGHT THE S1 VERTEBRAL BODY, AND THE BASEPLATE WAS ADVANCED FAR ENOUGH THAT THE USE OF THE REMOVAL TOOL WOULD DAMAGE THE TARGET VERTEBRAL BODY MORE THAN A TRIVIAL AMOUNT. THE DESCRIPTION OF THE EVENTS DETAILED IN THIS MDR REPRESENT INTRINSIC THERAPEUTIC'S UNDERSTANDING AT THE TIME OF SUBMISSION. 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 UPDATES/TRENDS.

    Description of Event or Problem · 0

    THE MESH BUCKLED WHILE IMPLANTING INTO L5 VERTEBRAL BODY. THE IMPLANT HAD TO BE REMOVED WITH THE REMOVAL TOOL WHICH WAS DONE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833110 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 05072401 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown