BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 23314124 · Received October 16, 2025

    Report

    Report Number
    3006232063-2025-00039
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 16, 2025
    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

    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 NEW INFORMATION SUBMITTED, ANOTHER FOLLOW-UP WILL BE COMPLETED. INTRINSIC THERAPEUTICS WILL CONTINUE TO MONITOR FOR UPDATES/TRENDS.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH A BARRICAID DEVICE ON (B)(6) 2025. THE PATIENT EXPERIENCED ANOTHER HERNIATION AT THE SAME LEVEL. THE SURGEON PERFORMED A REVISION MICRODISCECTOMY ON (B)(6) 2025 AND DID NOT REMOVE THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2550396 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 05092501 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention