BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 19981289 · Received August 14, 2024

    Report

    Report Number
    3006232063-2024-00029
    Event Type
    Injury
    Date Received
    August 14, 2024
    Date of Event
    July 15, 2024
    Report Date
    August 14, 2024
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    UDI-DI
    M906BARA88MM0
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 INFORMATION ANOTHER FOLLOW-UP WILL BE COMPLETED. INTRINSIC THERAPEUTICS WILL CONTINUE TO MONITOR FOR UPDATES/TRENDS.

    Description of Event or Problem · 0

    THE DEVICE WAS REMOVED ON (B)(6) 2024 TO MAKE ROOM FOR A FUSION CAGE. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE TO SURGEON, AND THEY PROVIDED THE FOLLOWING DETAILS ON (B)(6) 2024: "THE IMPLANT WAS REMOVED FOR SEVERAL REASONS BUT THERE WAS NO APPARENT DEVICE MALFUNCTION OR DEFECT. THE PATIENT HAD PERSISTENT RADICULOPATHY AND HAD EITHER RECURRENT OR RESIDUAL DISC MATERIAL AROUND THE IMPLANT IMPINGING ON THE TRAVERSING NERVE ROOT. IN ADDITION, THE DEVICE WAS NOT FULLY SEATED INTO THE S1 VERTEBRA AND PROTRUDED POSTERIORLY INTO THE CANAL LIKELY ALSO CONTRIBUTING TO HIS ONGOING SYMPTOMS. FINALLY, HE DID ALSO HAVE SOME SUBTLE ANTEROLISTHESIS AT THE OPERATIVE SEGMENT, SO FUSION WAS INDICATED. HOPE THIS IS ADEQUATE INFORMATION, BUT LET ME KNOW IF I CAN CLARIFY FURTHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233817 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 08162101 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other