BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 21606695 · Received March 14, 2025

    Report

    Report Number
    3006232063-2025-00015
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 14, 2025
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    UDI-DI
    M906BARA88MM0
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Product Problem
    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 DEFECT IN THE ANULUS WAS TIGHT, AND THE IMPLANT GOT CAUGHT IN THE ANNULUS AND BUCKLED. THE IMPLANT WAS IMPACTED TO TRY AND PUSH THROUGH THE OBSTRUCTION, BUT DIDN'T SUCCEED. THE SURGEON MADE A SURGICAL INTERVENTION AND USED A REMOVAL TOOL TO REMOVE THE DAMAGED DEVICE AND THIS CAUSED SOME MINOR DAMAGE (BONE REMOVAL) TO THE VERTEBRA BEYOND WHAT IS CONSIDERED TRIVIAL. NO NEGATIVE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229092 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 09092402 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention