BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIOS XENOGRAFT GRANULES

    MDR report key: 6227247 · Received January 5, 2017

    Report

    Report Number
    2249852-2017-00001
    Event Type
    Injury
    Date Received
    January 5, 2017
    Report Date
    July 5, 2017
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    NPM
    UDI-DI
    M440323100010
    PMA / PMN Number
    K140714
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    REPORT OF EXUBERANT GROWTH OF BULBOUS, FIBROUS MASS OVER THE EXTRACTION SITE WAS RECEIVED, THE MASS WAS EXCISED AND SUBMITTED FOR HISTOPATHOLOGICAL EVALUATION BY THE CLINICIAN. COLLAGEN MATRIX, INC. HAS NOT RECEIVED THE EVALUATION RESULTS FROM THE REPORTING CLINICIAN. THE PRODUCT WAS LEFT IN PLACE AND THE PATIENT WAS DOING WELL AT THE TIME OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10037 SYMBIOS XENOGRAFT GRANULES PORCINE ANORGANIC BONE MINERAL NPM COLLAGEN MATRIX, INC. PMCU15H3 M440323100010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 4-0 CHROMIC GUT SUTURES| ORAPLUG