BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 15833355 · Received November 21, 2022

    Report

    Report Number
    3006232063-2022-00022
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    May 16, 2022
    Report Date
    November 10, 2022
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    UDI-DI
    M906BARA810MM0
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SURGEON WAS INTERVIEWED AFTER THE SURGERY, AND THEY AGREED THAT THEY WERE USING AN ANGLE THAT WAS TOO STEEP FOR THE INITIAL INSERTION. THE SURGEON WAS INSTRUCTED WHEN THE BUCKLING WAS NOTICED, TO REPLACE THE DAMAGED IMPLANT AND WAS OFFERED A NEW IMPLANT BY THE INTRINSIC REPRESENTATIVE PRESENT AT THE TIME OF THE OPERATION. THEY DECIDED TO CONTINUE WITH USING THE DAMAGED IMPLANT WHICH CAUSED IT TO FAIL BY HAVING THE MESH BARRIER (SEAL) TO DETACH FROM THE ANCHOR. THIS FAILURE OF THE DEVICE WAS DUE TO IMPROPER TECHNIQUE INITIALLY AND CONTINUING TO USE A DAMAGED IMPLANT. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS ADVERSE EVENT.

    Description of Event or Problem · 0

    SURGEON INSERTING THE BARRICAID IMPLANT AND NOTICED THE MESH STARTING TO BUCKLE. THE SURGEON THEN REMOVED THE FAILED IMPLANT WITH MESH BUCKLING AND ATTEMPTED A SECOND IMPLANTATION USING THE SAME DAMAGED IMPLANT. THE BUCKLED MESH THEN CONTINEUD TO BUCKLE AND IT DETACHED FROM THE ANCHOR. THEN THE SURGEON REMOVED THE NOW SEPARATED MESH AND SUNK THE IMPLANT FURTHER INTO THE VERTEBRAL BODY. ANCHOR REMAINS IMPLANTED AND THE PATIENT WAS CLOSED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559163 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-10MM 04302120 M906BARA810MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Unknown Required Intervention