BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX

    MDR report key: 1952034 · Received December 30, 2010

    Report

    Report Number
    1213643-2010-00578
    Event Type
    Injury
    Date Received
    December 30, 2010
    Report Date
    December 6, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTM
    PMA / PMN Number
    K081272
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT INDICATES THAT THE PATIENT HAD AND WAS TREATED FOR A RECURRENCE, WHICH IS A KNOWN POSSIBLE ADVERSE EVENT LISTED IN THE IFU. THE REPORT DOES NOT SPECIFY A SPECIFIC PRODUCT PROBLEM AND NO PRODUCT WAS RETURNED FOR EVALUATION, THEREFORE, BASED ON THE CURRENTLY AVAILABLE INFORMATION, THERE IS NO INDICATION THAT A FAILURE IN THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE SURGEON, AT THE TIME OF IMPLANT, SUSPECTED THAT THE PATIENT WOULD REQUIRE ADDITIONAL SURGICAL INTERVENTION AS THE PATIENT HAD ISSUES WITH THE HOST TISSUE. THE SURGEON REPORTED THE OUTCOME WAS RELATED TO THE PATIENT'S CO-MORBIDITIES AND TISSUE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT XENMATRIX IMPLANT DURING OPEN PROCEDURE. THE GRAFT WAS PLACED USING A BRIDGE TECHNIQUE. ACCORDING TO THE SURGEON, AT THE TIME OF IMPLANT, HE SUSPECTED THE PATIENT WOULD REQUIRE ADDITIONAL SURGICAL INTERVENTION AS THE PATIENT HAD ISSUES WITH THEIR HOST TISSUE. THE SURGEON REPORTED THE OUTCOME WAS RELATED TO THE PATIENT'S CO-MORBIDITIES AND TISSUE. AT AN UNKNOWN SUBSEQUENT DATE, THE PATIENT UNDERWENT A 'REDO' PROCEDURE WHERE THE XENMATRIX WAS EXPLANTED AND ANOTHER PIECE OF XENMATRIX WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENMATRIX FTM DAVOL INC., SUB. C.R. BARD, INC. NA HUUABL01

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention