BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 23439498 · Received October 31, 2025

    Report

    Report Number
    3006232063-2025-00042
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 2, 2025
    Report Date
    May 27, 2026
    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
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE DESCRIPTION OF THE ISSUE AND THE IMAGES SHARED, THE PATIENT APPEARS TO HAVE REHERNIATED AND THE BARRIER (SEAL) PORTION OF THE DEVICE MIGRATED WITH THE HERNIATED MATERIAL. 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

    BASED ON PERSONAL COMMUNICATION FROM A WORK COLLEAGUE, THE PATIENT HAD AXIAL BACK PAIN AND HAD MRI AND X-RAY IMAGING. THE IMAGES SHOWED MIGRATION OF THE MESH MARKER OUT OF THE DISC SPACE AND COMPRESSION OF THE NERVE ROOT DUE TO A REHERNIATION. THE PATIENT HAS ONLY HAD IMAGING PERFORMED AND HAS NOT YET HAD A FOLLOW-UP VISIT WITH THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165088 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 06152001 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1