BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 22105499 · Received May 29, 2025

    Report

    Report Number
    3006232063-2025-00020
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    April 30, 2025
    Report Date
    May 29, 2025
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    UDI-DI
    M906BARA88MM0
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ORIGINAL IMPLANTATION ON (B)(6) 2024 WAS REPORTED AS 2 IMPLANTS USED (THE FIRST WAS REMOVED). A SECOND IMPLANT WAS INSERTED INTO THE SPACE THAT THE INITIAL DEVICE HAD CREATED. THE FINAL IMPLANTED DEVICE HAD IMAGES TAKEN AT (ESTIMATED) 5 MONTHS POST OP THAT SHOWED SOME MOVEMENT FROM THE INITIAL LOCATION. ON 30-APR-2025, A REPORT CAME IN OF A DEVICE MIGRATION OUT OF THE VERTEBRA AND A TREATMENT PLAN IS BEING DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717292 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 01192301 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other