BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN 2X2 1 PACK DOMESTIC

    MDR report key: 3122089 · Received May 16, 2013

    Report

    Report Number
    2648988-2013-00017
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 16, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    PMA / PMN Number
    K 982180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A PATIENT UNDERWENT A SPINAL FUSION TO IMPLANT RODS AND SCREWS; (SYNTHES), PLEBIUS BLOCKS (SYNTHES) AND INFUSED WITH A BONE GRAFT (MEDTRONIC SOFAMORE DANEK). A PIECE OF DURAGEN WAS USED AS WELL DURING THIS PROCEDURE. ON (B)(6) 2013, THE PATIENT DEVELOPED A FEVER FOR WHAT WAS SUSPECTED TO BE A WOUND INFECTION, ALTHOUGH AS OF THIS DATE ON (B)(6) 2013 A WOUND INFECTION HAS NOT BEEN CONFIRMED. THE PATIENT'S TREATMENT WAS COMPRISED OF THE WOUND DRAINAGE, DEBRIDING AND SUTURING. THE PATIENT WAS DISCHARGED HOME. THE PATIENT'S CONDITION HAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217409 DURAGEN 2X2 1 PACK DOMESTIC NA GXQ INTEGRA LIFESCIENCES CORPORATION 1112228

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention