BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 2119919 · Received June 8, 2011

    Report

    Report Number
    2183620-2011-00043
    Event Type
    Injury
    Date Received
    June 8, 2011
    Report Date
    May 9, 2011
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE REPORTS SUBMITTED FOR THE SAME ABSTRACT ARE MANUFACTURER REPORT NUMBERS: 2183620-2011-00044 AND 2183620-2011-00045. NO PRODUCT WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. HANABERGH JR. E, ET AL: BOVINE PERICARDIUM APPLICATION IN ABDOMINAL WALL RECONSTRUCTION. SOUTH FLORIDA CHAPTER OF THE AMERICAN COLLEGE OF SURGEONS. APRIL 28, 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ABSTRACT THAT A RETROSPECTIVE REVIEW OF ALL ABDOMINAL WALL RECONSTRUCTIONS UTILIZING BIOLOGIC BASED MESH MATERIALS PERFORMED AT (B)(6) CLINIC FROM 2008-2010 WERE REVIEWED. EACH RECONSTRUCTION WAS PERFORMED BY COMPONENT SEPARATION TECHNIQUE (CST) AND REINFORCED WITH BIOLOGIC MESH MATERIALS. A TOTAL OF 39 CASES OF ABDOMINAL WALL RECONSTRUCTIONS WERE IDENTIFIED. OF THE 39 CASES, 16 WERE IMPLANTED WITH HUMAN ACELLULAR DERMAL MATRIXES (HADM) FOR REINFORCEMENT ONLAY AND 23 WERE IMPLANTED WITH BOVINE PERICARDIUM (BP) (VERITAS COLLAGEN MATRIX) AS THE BIOLOGIC ONLAY . OF THE 23 VERITAS IMPLANTS, A POST OPERATIVE COMPLICATION OF A RECURRENCE WAS REPORTED. DETAILS REGARDING THE CASE WERE NOT AVAILABLE. THE ABSTRACT REPORTS THAT THE "CASE SERIES DEMONSTRATES THAT USING BP AS OPPOSED TO HADM FOR REINFORCEMENT FOLLOWING CST IN OUR PRACTICE IS ASSOCIATED WITH A REDUCTION IN INFECTION AND RECURRENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERITAS COLLAGEN MATRIX SURGICAL MESH FTM SYNOVIS SURGICAL INNOVATIONS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention