BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 5999709 · Received October 5, 2016

    Report

    Report Number
    2530154-2016-00014
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    February 20, 2016
    Report Date
    October 4, 2016
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    OXK
    UDI-DI
    00081233702034
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER HAS NOT BEEN PROVIDED. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED, BUT NOT AVAILABLE AS OF DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT A PATIENT UNDERWENT A COMPONENT SEPARATION, DONE THROUGH A LARGE CHEVRON INCISION, AND HAD A LARGE PIECE OF XCM BIOLOGIC TISSUE MATRIX PLACED IN THE RETRORECTUS SPACE WITHOUT SUTURES. SIX MONTHS POST-OP, THE PATIENT PRESENTED WITH A FLANK HERNIA ON ONE SIDE OF THE CHEVRON. DURING LAPAROSCOPIC SURGERY TO REPAIR THE HERNIA, THE SURGEON NOTED THAT WHERE THE HERNIA DEVELOPED THE TISSUE WAS SOFT, AS IF THE PREVIOUSLY PLACED XCM BIOLOGIC TISSUE MATRIX WAS NO LONGER PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652901 XCM BIOLOGIC TISSUE MATRIX MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS OXK DSM BIOMEDICAL 30010-34 00081233702034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention