BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 20261644 · Received September 19, 2024

    Report

    Report Number
    3006232063-2024-00036
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 22, 2024
    Report Date
    September 19, 2024
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    UDI-DI
    M906BARA810MM0
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMAGING PROVIDED TO INTRINSIC WAS PERFORMED AT 8 MONTH FOLLOW UP AND SHOWS THE MESH HAD MIGRATED OUT OF THE DISC SPACE. THE BARRICAID IMPLANT WAS PARTIALLY REMOVED TO MAKE ROOM FOR THE TLIF DURING THE SURGICAL INTERVENTION. THE REMOVED COMPONENTS WERE SENT TO A 3RD PARTY LABORATORY FOR ANALYSIS, AND THOSE RESULTS HAVE NOT BEEN COMMUNICATED TO INTRINSIC AT THE DATE OF THIS REPORT. 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 SURGEON REPORTED TO INTRINSIC THAT A FUSION (TLIF) WAS PERFORMED ON THIS PATIENT 3.8 YEARS (ESTIMATED) AFTER IMPLANTATION. THE PATIENT REPORTED SYMPTOMATIC BACK PAIN AT 8 MONTHS POST OPERATION AND WITHIN 3 MONTHS OF THAT REPORT THE SYMPTOMS WERE INTERMITTENT, AND THE PATIENT DECIDED TO WAIT IT OUT TO SEE IF IT IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335756 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-10MM 06112002 M906BARA810MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other