BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PRECLUDE DURA SUBSTITUTE

    MDR report key: 3231945 · Received July 3, 2013

    Report

    Report Number
    3007284313-2013-00052
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    September 1, 2008
    Report Date
    June 7, 2013
    Manufacturer
    W. L. GORE ASSOCIATES
    Product Code
    GXQ
    PMA / PMN Number
    K984534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: HATA, N, ET AL. FOREIGN BODY GRANULOMA ASSOCIATED WITH DURA-CRANIOPLASTY AFTER RESECTION OF CONVEXITY MENINGIOMA WITH EXTRACRANIAL EXTENSION; NEUROL MED CHIR (TOKYO) 2011:51; 236-238.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "FOREIGN BODY GRANULOMA ASSOCIATED WITH DURA-CRANIOPLASTY AFTER RESECTION OF CONVEXITY MENINGIOMA WITH EXTRACRANIAL EXTENSION" IT STATES A (B)(6) Y/O, MAN, UNDERWENT CRANIOTOMY AND DURAPLASTY FOR A NEOPLASM IN THE RIGHT PARIETAL REGION. FOLLOWING TUMOR RESECTION, DURAPLASTY WAS PERFORMED USING GORE PRECLUDE DURA SUBSTITUTE. A BONE FLAP WAS THEN PLACED OVER THE DEFECT USING HYDROXYAPATITE CEMENT. FIBRIN GLUE-BONDED AUTOLOGOUS BONE DUST WAS COATED ONTO THE INSIDE OF THE FLAP FOR REINFORCEMENT. ONE YEAR AFTER SURGERY THE PT HAD A SURGERY TO REMOVE A SECOND LESION IN THE SAME REGION. THE GORE PRECLUDE DURA SUBSTITUTE PATCH WAS REMOVED AND REPLACED WITH A NEW GORE PRECLUDE DURA SUBSTITUTE PATCH AND TITANIUM MESH. WHEN THE TUMOR WAS HISTOLOGICALLY EXAMINED, GRANULATION TISSUE WITH DENSE CHRONIC INFLAMMATORY INFILTRATION AND FOREIGN BODY REACTION AGAINST BONE DEBRIS WAS NOTED. THE PT DID WELL AFTER THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303584 GORE PRECLUDE DURA SUBSTITUTE GXQ/DURA SUBSTITUTE GXQ W. L. GORE ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R HUYDROXYAPATITIE CEMENT-INITIAL SURGERY| FIBRIN GLUE-INITIAL SURGERY