BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 5775060 · Received July 7, 2016

    Report

    Report Number
    2530154-2016-00010
    Event Type
    Injury
    Date Received
    July 7, 2016
    Date of Event
    June 15, 2016
    Report Date
    July 6, 2016
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    OXK
    UDI-DI
    00812337020312
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE LOT HISTORY RECORDS REVEALED NO DEVIATIONS THAT WOULD CONTRIBUTE TO SUTURE TEAR. GIVEN THE USE OF THE MESH TO BRIDGE A GAP IN THE RECTUS MUSCLES, EXCESSIVE FORCES ON THE ABDOMINAL WALL POST-OPERATIVELY MAY HAVE CONTRIBUTED TO THE MESH DETACHMENT. IN ADDITION, PRESENCE OF BOWEL CONTENTS IN THE ABDOMINAL CAVITY IS KNOWN TO DEGRADE BIOLOGIC MESH.

    Description of Event or Problem · 1

    THE PATIENT WAS FEMALE WITH A SIGNIFICANT SURGICAL HISTORY CONSISTING OF COLECTOMY, STOMA, STOMA REVERSAL, FISTULA, AND HERNIA REPAIR. ON (B)(6) 2016, ANOTHER ABDOMINAL SURGERY WAS PERFORMED THAT INVOLVED SIGNIFICANT ADHESIOLYSIS, FISTULA DEBRIDEMENT AND CLOSURE, AND RESECTION OF PREVIOUSLY PLACED MESH. THE SURGICAL SITE WAS CONSIDERED TO BE CONTAMINATED. THE SURGEON WAS NOT ABLE TO RE-APPROXIMATE THE RECTUS MUSCLES. THEREFORE, XCM BIOLOGIC WAS IMPLANTED TO BRIDGE THE GAP IN THE ABDOMINAL WALL. APPROXIMATELY 2 WEEKS LATER, THE PATIENT PRESENTED WITH WOUND DEHISCENCE AND A SMALL BOWEL FISTULA. UPON REOPERATION, THE SURGEON REPORTED THAT THE MESH HAD DETACHED FROM THE RIGHT SIDE AND WAS BUNCHED UP ON THE LEFT SIDE OF THE ABDOMEN. THE MESH WAS DESCRIBED AS JELLY-LIKE IN APPEARANCE. THE SURGEON REMOVED THE XCM BIOLOGIC MESH AND IMPLANTED VICRYL MESH TO COVER THE DEFECT. THE PATIENT WAS STILL IN THE HOSPITAL ONE WEEK LATER, BUT WAS NO LONGER SEPTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428632 XCM BIOLOGIC TISSUE MATRIX MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS OXK DSM BIOMEDICAL 30012-31 C1026 00812337020312

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention NYLON SUTURE