BEUDAMED
    FDA Adverse Event Summary report: N

    VERITAS COLLAGEN MATRIX-BIOLOGICAL IMPLANT

    MDR report key: 2142658 · Received June 16, 2011

    Report

    Report Number
    2142658
    Date Received
    June 16, 2011
    Date of Event
    January 1, 2010
    Report Date
    June 16, 2011
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN INCREASE IN INFECTIONS FOR PATIENTS RECEIVING BREAST IMPLANTS WHEN VERITAS COLLAGEN BIOLOGICAL WAS USED AS A LINER IN THE BREAST CAVITY TO SUPPORT THE BREAST IMPLANT HAD BEEN NOTED FROM (B) (6) 2010 TO (B) (6) 2011. IN 2010, 5 OUT OF 36 CASES RESULTED IN INFECTION AND REMOVAL OF IMPLANT AND REIMPLANTATION. THIS IS 14% OF IMPLANTS. IN 2011, 4 INFECTIONS OUT OF 10 CASES RESULTED IN INFECTION AND REMOVAL OF IMPLANT AND REIMPLANTATION. THIS IS 40% OF THE IMPLANTS PERFORMED SO FAR FOR 2011.INFECTION CONTROL IDENTIFIED THROUGH SURVEILLANCE THAT IT APPEARED THAT PATIENTS WHO HAD VERITAS COLLAGEN MATRIX WITH THEIR BREAST IMPLANTS WERE DEVELOPING A SURGICAL SITE INFECTION MORE FREQUENTLY THAN PATIENTS WHO HAD ANOTHER BRAND OF TISSUE MATRIX. AN INDEPTH ANALYSIS WAS DONE AND IT PROVED THAT THE PATIENTS WITH THE VERITAS COLLAGEN MATRIX WERE HAVING MORE INFECTIONS THAN THE PATIENTS WITH ANOTHER BRAND OF TISSUE MATRIX. DISCUSSED WITH PLASTIC SURGEONS AND REMOVED VERITAS COLLAGEN MATRIX FROM SERVICE IN (B) (6) 2011.====================== MANUFACTURER RESPONSE FOR BREAST IMPLANT, VERITAS COLLAGEN MATRIX-BIOLOGICAL IMPLANT (PER SITE REPORTER)======================NOTHING YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERITAS COLLAGEN MATRIX-BIOLOGICAL IMPLANT TISSUE MATRIX FTM SYNOVIS SURGICAL INNOVATIONS SYNOVIS 10053 5774195-1414289 (ALL DIFF LOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 *