BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 16108042 · Received January 5, 2023

    Report

    Report Number
    3006232063-2022-00053
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 7, 2022
    Report Date
    January 5, 2023
    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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO IMAGES WERE AVAILABLE TO REVIEW SO INVESTIGATION WAS LIMITED TO THE EVENT DETAILS REPORTED.

    Description of Event or Problem · 0

    AN IMPLANTATION ATTEMPT WAS MADE INTO THE S1 VERTEBRAL BODY. THIS ATTEMPT EXPERIENCED A BUCKLING AND FRACTURE OF THE GUIDEWIRE AND THE IMPLANT WAS FAR ENOUGH INTO THE BONE THAT THE REMOVAL TOOL WAS USED TO EXTRACT THE DEVICE. THE PHYSICIAN ELECTED TO NOT CLOSE THE DEFECT IN THE DISC WALL AND CLOSED THE PATIENT WITHOUT A BARRICAID IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724117 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 03212202 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other