BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 15052339 · Received July 19, 2022

    Report

    Report Number
    3006232063-2022-00001
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Date of Event
    January 5, 2022
    Report Date
    July 18, 2022
    Manufacturer
    INTRINSIC THERAPEUTICS, INC.
    Product Code
    QES
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD AN INITIAL IMPLANT OF THE BARRICAID ON (B)(6) 2019. THE PATIENT STARTED EXPERIENCING PAIN ON (B)(6) 2021. RE-OPERATION OCCURRED ON (B)(6) 2022. DURING SURGERY, A PROLAPSE WAS SEEN MEDIAL TO THE POLY MESH OF THE IMPLANT. THE MESH FLIPPED DORSALLY AND PARTIALLY FUSED TO THE DURA/ROOT. ISOLATED EXTRACTION OF THE MESH WAS NOT POSSIBLE. THE ANCHOR REMAINED IN THE VERTEBRAL BODY BECAUSE IT WAS FIRMLY ANCHORED IN THE BONE. AFTER PERFORMANCE OF THE SEQUESTROTOMY THE WOUND WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251497 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC. BAR-D8-12X14 12041803

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention