BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAGEN PLUS DURAL REGENERATION MATRIX 2X2 1 PA

    MDR report key: 1593848 · Received February 2, 2010

    Report

    Report Number
    1121308-2010-00006
    Event Type
    Malfunction
    Date Received
    February 2, 2010
    Report Date
    February 2, 2010
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INFO.

    Description of Event or Problem · 1

    SURGERY WAS PERFORMED ON (B)(6) 2010. THE PT DEVELOPED A CEREBRAL SPINAL FLUID LEAK REQUIRING SURGICAL REVISION ON (B)(6) 2010. THE SURGEON REPORTED THAT THEY NOTICED THAT THE DURAGEN PLUS (DP1022) DID NOT ADHERE TO THE BED AND THE PIECE HAD SHIFTED. THE SURGEON CLOSED THE WOUND WITH A COMPETITIVE PRODUCT. NO PT INJURY OCCURRED AS A RESULT OF THE EVENT. ADD'L CLINICAL INFO REQUESTED FROM THE REPORTING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAGEN PLUS DURAL REGENERATION MATRIX 2X2 1 PA NA GXQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention