BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 7209109 · Received January 22, 2018

    Report

    Report Number
    2530154-2018-00001
    Event Type
    Injury
    Date Received
    January 22, 2018
    Date of Event
    November 30, 2016
    Report Date
    January 17, 2018
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    OXK
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XCM BIOLOGIC TISSUE MATRIX WAS USED TO RECONSTRUCT THE ANTEROLATERAL THORACIC WALL AND WAS COVERED WITH A MYOCUTANEOUS LATISSIMUS DORSI MUSCLE FLAP. THE THORACIC WALL RESECTION WAS DUE TO CHRONIC OSTEOMYELITIS OF THE THORACIC WALL AFTER RADIOGENIC DAMAGE. THERE WAS A LOCAL INFECTION WITH A NEED FOR RE-OPERATION. DURING THE REVISION, AFTER DETACHMENT OF THE VITAL AND WELL-PERFUSED MUSCLE FLAP, THE MEMBRANE WAS COMPLETELY DECOMPOSED AND THERE WAS A DIRECT VIEW OF THE LUNGS AND OTHER INTRA-THORACIC ORGANS. FOR DISCUSSION IS WHETHER THE IMPLANT IS NOT EXPLICITLY DECLARED AS CONTRAINDICATED IN CASE OF POSSIBLE INFECTION. THE IMPLANT WAS USED BECAUSE IT IS A BIOLOGIC AND SHOULD BE CONSIDERED LESS SUSCEPTIBLE TO INFECTION. THIS COMPLAINT INVOLVES 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53662 XCM BIOLOGIC TISSUE MATRIX MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS OXK DSM BIOMEDICAL 30012-25 KND6413

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention