BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID

    MDR report key: 10393996 · Received August 11, 2020

    Report

    Report Number
    3006232063-2019-00004
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    October 9, 2018
    Report Date
    April 1, 2019
    Manufacturer
    INTRINSIC THERAPEUTICS
    Product Code
    QES
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE MANUFACTURING RECORDS REVIEW CONDUCTED BY INTRINSIC SHOWED THAT THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. DEVICE WAS DISCARDED AND NOT RETURNED FOR EVALUATION. THERE IS NO SUGGESTION FROM THE SURGEON OR THE PERI-OPERATIVE IMAGING THAT THERE WAS AN ISSUE WITH THE INITIAL PLACEMENT OF THE DEVICE. BASED ON THE CT IMAGING, THE MIGRATION OF THE MESH COMPONENT INTO THE SPINAL CANAL WAS CONFIRMED. DEVICE SEPARATION AND MIGRATION ARE KNOWN INHERENT RISKS IDENTIFIED IN THE DEVICE IFU WITH OCCURRENCE RATES LOWER THAN THOSE STATED IN OUR DEVICE IFU WHICH ARE DETERMINED AND BASED UPON THE PIVOTAL SUPERIORITY STUDY. IN SIMILAR COMPLAINTS, THE POSSIBLE CAUSE OF THE OCCLUSION COMPONENT MIGRATION WAS MECHANICAL LOADING ON THE OCCLUSION COMPONENT DUE TO INTRADISCAL PRESSURE DEVELOPED IN RESPONSE TO THE PATIENT'S ACTIVITIES.

    Description of Event or Problem · 1

    THE DIAGNOSIS WAS A RECURRENT HERNIATION AT L5/S1 LEFT. ADDITIONALLY, THE IMAGING INDICATED THAT THE MESH COMPONENT HAD MIGRATED INTO THE EPIDURAL SPACE. A REOPERATION WAS PERFORMED TO REMOVE THE HERNIATION AND DETACHED MESH COMPONENT. THE SURGEON INDICATED THAT SCAR TISSUE HAD GROWN TOGETHER WITH THE MESH COMPONENT. THE MESH COMPONENT WAS REMOVED IN PIECES. THE SURGEON MENTIONED THAT SCAR TISSUE MADE THE REOPERATION MORE CHALLENGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858404 BARRICAID 12 MM BARRICAID QES INTRINSIC THERAPEUTICS 2731015-EU 12141602

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention