BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 3403850 · Received September 19, 2013

    Report

    Report Number
    2530154-2013-00009
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Date of Event
    August 14, 2013
    Report Date
    September 19, 2013
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD CODE: LOT HISTORY RECORDS REVIEWED. RESULTS: USE OF NON CROSS-LINKED BIOLOGIC MESH TO BRIDGE A DEFECT IN THE ABDOMINAL WALL IN A CLEAN-CONTAMINATED OR CONTAMINATED SURGICAL SITE IS ASSOCIATED WITH A MODERATE RATE OF DEFECT RECURRENCE. THE TEAR PATTERN INDICATES THAT THE DEVICE WAS UNDER EXTREME TENSION, AND DID NOT FAIL AT ONE SINGLE POINT. RATHER, THE DEVICE RUPTURED UNDER CONCENTRATION FORCE. IT WAS NOTED THAT THE TEARS SEEM TO COME FROM A CENTRAL POSITION WITHIN THE DEVICE AND THE TEAR LINES' SEVERITY DECREASED CLOSER TO THE DEVICE EDGES. THEREFORE, THE PATIENT'S CONDITION IS PRESUMED TO BE CONTRIBUTING FACTOR. HOWEVER, THE EXACT CAUSE OF THE TEAR CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PATIENT HAD SURGERY FOR ABDOMINAL EVENTRATION AND COLOSTOMY. DURING THE SURGERY XCM BIOLOGIC WAS IMPLANTED TO BRIDGE A LARGE GAP IN THE ABDOMINAL WALL. IT WAS REPORTED THAT THE PATIENT HAD AN UNCONTROLLED FEVER ON THE DAY AFTER SURGERY. THEREFOR, THE SURGEON DECIDED TO BRING THE PATIENT BACK TO THE OPERATING ROOM. DURING THIS SECOND SURGERY, THE SURGEON OBSERVED A TEAR IN THE MIDDLE OF THE MESH. THE TORN MESH WAS EXPLANTED AND THE SKIN WAS CLOSED. NO OTHER MESH WAS IMPLANTED TO REPAIR THE ABDOMINAL WALL EVENTRATION. IT WAS REPORTED THAT THE PATIENT HAS BEEN DISCHARGED AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474722 XCM BIOLOGIC TISSUE MATRIX BIOLOGIC SURGICAL MESH FTM DSM BIOMEDICAL 30012-32 93362

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention PDS SUTURE