BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 3123699 · Received May 13, 2013

    Report

    Report Number
    2530154-2013-00004
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 14, 2013
    Report Date
    May 13, 2013
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD (OTHER): LOT HISTORY RECORDS REVIEWED. PHOTOGRAPHS TAKEN DURING REVISION SURGERY REVIEWED. AS OF THE DATE OF THIS REPORT, THE ACTUAL EXPLANTED DEVICE IS IN TRANSIT FROM OVERSEAS. RESULTS: NO DEVIATIONS WERE FOUND DURING LOT HISTORY RECORDS REVIEW THAT WOULD BE EXPECTED TO CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT. PHOTOGRAPHS TAKEN DURING REVISION SURGERY SHOW TEARS NEAR OR ALONG THE SUTURE LINE. CONCLUSION: AS OF THE DATE OF THIS INITIAL MDR, NO CONCLUSION CAN BE MADE REGARDING THE CAUSE OF THE DEVICE TEAR. IF ADD'L CLINICAL INFO IS PROVIDED AND/OR THE PRODUCT IS RECEIVED IN A CONDITION THAT ALLOWS FOR PRODUCT EVAL, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(6) MALE HAD ABDOMINAL WALL RECONSTRUCTION AND A 20 X 30CM XCM BIOLOGIC TISSUE MATRIX WAS IMPLANTED FOR REINFORCEMENT. AS OF THE DATE OF THIS REPORT, IT IS NOT CLEAR WHETHER THE ABDOMINAL RECTUS FASCIA WAS REAPPROXIMATED AT THE MIDLINE AND CLOSED OR WHETHER THE BIOLOGIC MESH WAS USED TO BRIDGE A GAP BETWEEN THE RECTUS MUSCLES. ON POST-OPERATIVE DAY 2, IT WAS REPORTED THAT THE BIOLOGIC MESH TORE ON ONE SIDE NEAR THE SUTURE LINE. NO INFO HAS BEEN PROVIDED ABOUT THE PATIENT'S POST-OPERATIVE CONDITION AT THE TIME OF THE REPORTED TEAR. ON POST-OPERATIVE DAY 11, A REVISION PROCEDURE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210877 XCM BIOLOGIC TISSUE MATRIX BIOLOGIC SURGICAL MESH FTM KENSEY NASH CORP. 30012-32 A5451

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention