BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX REGENERATIVE MEMBRANE-TITANIUM REINFORCED

    MDR report key: 1511482 · Received October 19, 2009

    Report

    Report Number
    3003910212-2009-00027
    Event Type
    Injury
    Date Received
    October 19, 2009
    Date of Event
    March 31, 2009
    Report Date
    October 16, 2009
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    NPK
    PMA / PMN Number
    K960292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE REMAINS IMPLANTED, REVIEW OF INFORMATION PROVIDED BY THE USER. BASED UPON THE AVAILABLE INFORMATION, THE EXACT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED, BUT THERE IS NO INDICATION THAT A DEVICE DEFECT OR MALFUNCTION WAS INVOLVED. THE POTENTIAL FOR DEVICE EXPOSURE AFTER IMPLANTATION IS ADDRESSED IN THE CAUTIONS SECTION OF THE INSTRUCTIONS FOR USE, STATING, "MATERIAL THAT IS PLACED IN A SUBMERGED APPLICATION SHOULD REMAIN IN PLACE 3 TO 9 MONTHS OR UNTIL BONE REGENERATION IS COMPLETE. HOWEVER, IF EXPOSED, IT IS RECOMMENDED THAT SHORTER TERM REMOVAL (AT APPROX. 4-12 WEEKS) BE ACCOMPLISHED TO AVOID COMPROMISING THE REGENERATIVE RESULT." ADDITIONALLY, THE POST-OPERATIVE REMINDERS INDICATE, "DO NOT ATTEMPT TO COVER MATERIAL THAT HAS BEEN EXPOSED. EXPOSURE OF THE MATERIAL SHOULD NOT INTERFERE WITH REGENERATION IF CLOSELY MONITORED." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GORE-TEX REGENERATIVE MEMBRANE BECAME EXPOSED APPROXIMATELY 3 MONTHS AFTER IMPLANTATION FOR GUIDED BONE REGENERATION. THE DENTIST USED A TISSUE GRAFT TO COVER THE EXPOSURE. THE DEVICE REMAINS IMPLANTED, AND IS PLANNED FOR REMOVAL WITHIN 3 MONTHS UPON COMPLETION OF TREATMENT. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX REGENERATIVE MEMBRANE-TITANIUM REINFORCED NPK/BARRIER, SYNTHETIC, INTRAORAL NPK W.L. GORE & ASSOCIATES,INC WLG503

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention