BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN PLUS DURAL REGENERATION MATRIX 1X1 1PAC

    MDR report key: 3113707 · Received May 10, 2013

    Report

    Report Number
    1121308-2013-00004
    Event Type
    Injury
    Date Received
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    PLAINSBORO CORPORATE OFFICE
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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

    FIRST REPORT OF FOUR PTS FROM THE SAME FACILITY WHO HAD DURAGEN IMPLANTED AND DEVELOPED A FEVER. THE FOUR CASES OF FEVER WERE DEFINED BY THE 2013 (B)(4) BIOVIGILLANCE PROTOCOL. (THE TEMPERATURE WAS GREATER THAN 100.4 DEGREES WITHIN 24 HOURS OF IMPLANTATION). THE MEDICAL CRITERIA WERE APPROVED FOR THIS REVIEW BY THE MEDICAL DIRECTOR OF THE TISSUE OVERSIGHT PROGRAM AND THE INFECTION PREVENTION AND CONTROL MANAGER. IT IS UNKNOWN WHETHER THESE CASES WERE REPORTED TO FDA. IF THE CASES WERE, IT WOULD HAVE BEEN REPORTED BY ANOTHER STAFF MEMBER FROM THIS FACILITY. AS A RESULT OF THIS PROTOCOL THE PTS FEVERS WERE ONLY FOLLOWED FOR THE FIRST 24 HOURS POSTOPERATIVELY. IT IS ALSO UNKNOWN WHETHER THE PTS HAD A FEVER PREOPERATIVELY (BASELINE), WHETHER THERE WAS ANY SURGICAL SITE INFECTION OR WHETHER THE HOSPITALIZATION WAS PROLONGED OR THE OUTCOME. THE DATE OF THE IMPLANT WAS (B)(6) 2011, DURING A PELVIC FUSION. HE DEVELOPED A FEVER OF 100.9 WITHIN THE FIRST TWENTY FOUR HOURS OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207520 DURAGEN PLUS DURAL REGENERATION MATRIX 1X1 1PAC NA GXQ PLAINSBORO CORPORATE OFFICE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR