BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 22479019 · Received July 11, 2025

    Report

    Report Number
    3006232063-2025-00029
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    June 13, 2025
    Report Date
    July 11, 2025
    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
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE WAS CONSIDERED AS REPORTABLE DUE TO THE USAGE OF THE REMOVAL TOOL CAUSING MORE THAN TRIVIAL DAMAGE TO THE VERTEBRA. THE PATIENT WAS SUCCESSFULLY IMPLANTED USING THE OPPOSITE VERTEBRA AND WAS REPORTED AS DOING WELL. 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 DISC SPACE WAS VERY TIGHT. ONCE WE BEGAN TAPPING ON THE INSERTION DEVICE IT BEGAN TO BUCKLE. A REMOVAL TOOL WAS USED, AND ANOTHER ATTEMPT WAS TRIED WITH A NEW IMPLANT SINCE THE NITINOL GUIDE WIRES WERE BENT OUT OF SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838673 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 04022501 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O