BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 10992313 · Received December 11, 2020

    Report

    Report Number
    3006232063-2020-00009
    Event Type
    Injury
    Date Received
    December 11, 2020
    Date of Event
    November 13, 2020
    Report Date
    December 10, 2020
    Manufacturer
    INTRINSIC THERAPEUTICS, INC.
    Product Code
    QES
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE PROBLEM FOUND.

    Description of Event or Problem · 1

    SURGEON REPORTED PATENT SUFFERING FROM CENTRAL BACK PAIN. UPON EXAMINATION, THE SURGEON SUSPECTED HERNIATION AGAINST NEURAL STRUCTURES THAT IS CAUSING THE PAIN. SURGEON WAS UNABLE TO FIND HERNIATION AFTER DISSECTION AND DECIDED TO REMOVE THE BARRICAID IMPLANT. REMOVAL WAS SUCCESSFUL. NEXT DAY SURGEON REPORTED PATIENT IS STILL HAVING SOME PAIN BUT DOING OK. IMPLANT FOUND IN SITU AS LEFT DURING INITIAL SURGERY. NO ADDITIONAL TREATMENT IS NECESSARY EXCEPT IMPLANT REMOVAL (NO NUCLEAR COMPRESSION FOUND).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454871 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC. BAR-A8-10MM 06/19/2023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention