BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 23360095 · Received October 22, 2025

    Report

    Report Number
    3006232063-2025-00040
    Event Type
    Injury
    Date Received
    October 22, 2025
    Report Date
    October 22, 2025
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DETAILS OF THE DEVICE IMPLANTED AND DATES INVOLVED ARE NOT YET KNOWN. THE YEAR 2018 IS KNOWN TO BE PRIOR TO US COMMERCIALIZATION. THIS DEVICE IS CONSIDERED SIMILAR TO THE BAR-A8-XXMM DEVICES THAT ARE MARKETED IN THE US UNDER THE PMA NUMBER DOCUMENTED ON THIS 3500A. THIS REPORT REPRESENTS THE LIMITED INFORMATION AT THE TIME OF THE REPORTING DEADLINE. ATTEMPTS ARE STILL BEING MADE TO GATHER INFORMATION. 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 SEPTEMBER 22, 2025, A REPORT CAME TO AN INTRINSIC REPRESENTATIVE FROM A PATIENT IN GERMANY. THE REPRESENTATIVE CONVEYED THE ISSUE AS, "THE PATIENT RECEIVED A BARRICAID IN 2018, NOW HAS RECURRING SYMPTOMS AND HAS BEEN BACK AT THE CLINIC". PATIENT UNDERWENT MRI AND CT AND IMAGES HAVE NOT YET BEEN SHARED. THE REPRESENTATIVE STATED THE PATIENT'S DESCRIPTION OF THEIR IMAGING AS HAVING "A LARGE ENDPLATE LESION". THE PATIENT IS SEEKING REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229490 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other