BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 23370898 · Received October 23, 2025

    Report

    Report Number
    3006232063-2025-00041
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    September 26, 2025
    Report Date
    October 23, 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

    ON (B)(6) 2025 THE SURGEON PERFORMED A TOTAL DISC REPLACEMENT (TDR) AND APPROACHED ANTERIORLY. THE SURGEON DETACHED THE POLYMER OCCLUSION COMPONENT AND THEN BROKE OFF THE ANCHOR HEAD AS WELL. BOTH WERE REMOVED COMPLETELY, AND NO FRAGMENTS WERE VISUALIZED VIA X-RAY. THE VERTICAL KEEL AND BASEPLATE WERE LEFT IN THE PATIENT. NO ADVERSE PATIENT OUTCOMES WERE REPORTED. FOLLOWING UP WITH THE SURGEON, IT WAS NOTED THAT THE PATIENT EXPERIENCED RECURRENT DISC PROTRUSION AND PERSISTENT DISCOGENIC PAIN AS THE NEED FOR A TDR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2816065 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 10112302 M906BARA88MM0

    Patients

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