BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMBRAGEL

    MDR report key: 1910642 · Received November 19, 2010

    Report

    Report Number
    1222315-2010-00017
    Event Type
    Injury
    Date Received
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BIORA AB
    Product Code
    NPK
    PMA / PMN Number
    K082111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    CLINICIAN REPORTS: INFECTION IN A SITE WHERE MEMBRAGEL WAS PLACED, 3 IMPLANTS PLACED AND 2 OF THE 3 IMPLANTS FAILED, INDICATION WAS SINUS AUGMENTATION, HAS NOT YET DETERMINED WHETHER THE ISSUE RELATES TO MEMBRAGEL, MEMBRAGEL WAS THE ONLY CHANGE IN HER TYPICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMBRAGEL BARRIER MEMBRANE NPK BIORA AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ALLOGRAFT WITH TETRACYDINE