BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 3960685 · Received June 9, 2014

    Report

    Report Number
    2530154-2014-00006
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    October 23, 2013
    Report Date
    June 12, 2014
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    OXB
    PMA / PMN Number
    K091499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL DEVICE AND CLINICAL INFORMATION. HOWEVER, AS OF THE DATE OF THIS REPORT, NO INVESTIGATION COULD BE COMPLETED SINCE THE DEVICE PART AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED. IF THE REQUESTED INFORMATION IS PROVIDED, IT WILL BE REPORTED IN A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT XCM BIOLOGIC WAS IMPLANTED FOR AN UNKNOWN SURGICAL PROCEDURE. THREE WEEKS LATER, REVISION SURGERY WAS PERFORMED DUE TO TUMOR MARGINS. IT WAS REPORTED THAT THE "XCM SHEET HAD DETERIORATED AND APPEARED AS A SLOUGHY AREA INSTEAD OF CHEST WALL TISSUE." THE PATIENT EXPERIENCED NO ASSOCIATED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333949 XCM BIOLOGIC TISSUE MATRIX MESH, SURGICAL, COLLAGEN, THORACIC OXB DSM BIOMEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR