BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 19229510 · Received May 2, 2024

    Report

    Report Number
    3006232063-2024-00016
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    April 3, 2024
    Report Date
    May 2, 2024
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    UDI-DI
    M906BARA810MM0
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION ANOTHER FOLLOW-UP WILL BE COMPLETED. INTRINSIC THERAPEUTICS WILL CONTINUE TO MONITOR FOR UPDATES/TRENDS.

    Description of Event or Problem · 0

    PHYSICIAN NOTIFIED INTRINSIC ABOUT A PATIENT WHO HAD WHAT APPEARED TO HAVE A MIGRATION OF THE OCCLUSION COMPONENT (MESH) INTO THE SPINAL CANAL. THE PHYSICIAN WHO SAW THE PATIENT WAS CONTACTED AND STATED, "HI! THE ORIGINAL IMPLANTATION DATE WAS (B)(6) 2022. THE PATIENT DID NOT HAVE A SPECIFIC INJURY OR INCIDENT TO CAUSE THIS. LAST XR IN JULY 2023 SHOWED STABLE IMPLANT. HE HAD ONE 2-3 WEEK SPAN OF MIDLINE AXIAL BACK ABOUT TWO MONTHS AGO. AND THEN IN THE MIDDLE OF MARCH HAD LEFT LOW BACK PAIN WITH LEFT LEG SYMPTOMS WHICH FELT SIMILAR TO HIS PREOP SYMPTOMS BUT THESE IMPROVED AFTER A FEW DAYS. THE PLAN RIGHT NOW IS TO UPDATE MRI LUMBAR SPINE AND THEN GO FROM THERE SINCE HIS SYMPTOMS HAVE IMPROVED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846755 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-10MM 11172003 M906BARA810MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other