BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 23778196 · Received December 11, 2025

    Report

    Report Number
    3006232063-2025-00050
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 13, 2025
    Report Date
    December 11, 2025
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    PATIENT REHERNIATED AFTER BARRICAID WAS IMPLANTED. THE DISC SPACE COLLAPSED SO THE SURGEON DECIDED TO PERFORM A TLIF AND REMOVE THE BARRICAID. ONCE IN THE CASE, THE SURGEON FOUND IT DIFFICULT TO REMOVE BARRICAID, SO HE DECIDED TO LEAVE IT IN AND PLACE THE TLIF CAGE ALONGSIDE BARRICAID IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2776769 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 10102402

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other