BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 23756383 · Received December 9, 2025

    Report

    Report Number
    3006232063-2025-00049
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 9, 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 REPORT OF A REMOVAL CAME WITH LIMITED DETAILS. SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER DETAILS FROM THE REPORTING SURGEON, BUT NO ADDITIONAL DETAILS HAVE BEEN PROVIDED BY THE DUE DATE FOR THIS 3500A. THE CAUSE OF THE FORAMINAL DISC PROTRUSION IS UNKNOWN AND NOT CLEAR IF THIS OCCURRED AROUND THE IMPLANT OR IN ANOTHER PART OF THE DISC WHERE THE BARRICAID IMPLANT DOES NOT RESIDE. 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 REPORTED TO HAVE A FORAMINAL DISC PROTRUSION WITH A PRIOR BARRICAID AND UNDERWENT AN ALIF PROCEDURE. THE IMPLANT WAS REMOVED USING A PITUITARY RONGEUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2008863 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other