BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 7593151 · Received June 12, 2018

    Report

    Report Number
    2530154-2018-00004
    Event Type
    Injury
    Date Received
    June 12, 2018
    Date of Event
    November 28, 2017
    Report Date
    June 11, 2018
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    OXK
    PMA / PMN Number
    KO91499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE D6860 BATCH RECORD AND IT'S ASSOCIATED INTERMEDIATE MANUFACTURING PROCESSES (PN 6445-30 LN D4559, PN 6199-03 LN D5851) CONFIRMED THERE WERE NO DISCREPANCIES ASSOCIATED WITH THE PRODUCT THAT COULD HAVE IMPACTED PRODUCT PERFORMANCE. ADDITIONALLY, FOR THIS PRODUCT, THERE IS NO INFORMATION IN THE IFU FOR USE ON PATIENTS UNDERGOING RADIATION THERAPY. UPON REVIEW OF THE RISK ASSESSMENT AND CURRENT CONTROLS IN PLACE, IT WAS DETERMINED THAT THE CONTROLS REFERENCED IN THE RISK ANALYSIS REMAIN ACCEPTABLE AND APPLICABLE AT THIS TIME. WITH A DHF REVIEW AND RISK ASSESSMENT REVIEW BEING COMPLETED, ALL CONTROLS WERE CORRECTLY IMPLEMENTED AND THERE WERE NO DISCREPANCIES DURING MANUFACTURING AND NO ASSIGNABLE ROOT CAUSE CAN BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME POSTOPERATIVE COMPLICATIONS WITH THE XCM BIOLOGIC TISSUE MATRIX WERE RECORDED AFTER IMPLANTATION OF THE XCM SHEET TOGETHER WITH THE MATRIXRIB PLATING SYSTEM AFTER CHONDROSARCOMA TUMOR REMOVAL IN (B)(6) 2017. PATIENT RECEIVED RADIATION THERAPY TO THE SURGICAL SITE FOR SIX WEEKS DURING (B)(6), DURING WHICH THE PATIENT HAD A LARGE AMOUNT OF DISCHARGE. PATIENT HAD PROCEDURES FOR DRAINAGE OF A RECURRENT PLEURAL EFFUSION IN BOTH (B)(6) AND (B)(6) 2017. THE WOUND WAS REOPENED IN (B)(6) 2017 AND IT WAS OBSERVED THAT THE XCM APPEARED TO BE DISSOLVING. THE XCM WAS REMOVED AND SUBSEQUENTLY NO FURTHER DRAINAGE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433266 XCM BIOLOGIC TISSUE MATRIX MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS OXK DSM BIOMEDICAL 30010-30 KND6860

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SYNTHES MATRIXRIB IMPLANT