BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURA NO-REACT DURAL SUBSTITUTE 6CM X 10CM

    MDR report key: 980377 · Received November 14, 2007

    Report

    Report Number
    3003418325-2007-00019
    Event Type
    Malfunction
    Date Received
    November 14, 2007
    Report Date
    November 14, 2007
    Manufacturer
    SHELHIGH INC
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    ITEGRA LIFESCIENCES CORP IS FILING A DISTRIBUTOR REPORT BASE UPON INFO PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 1

    ON 10/24/2007 INTEGRA LIFESCIENCES RECEIVED A LETTER FROM THE FDA INDICATING THAT A VOLUNTARY MEDWATCH HAD BEEN FILED BY USER FACILITY ON THE ENDURA DURAL GRAFT. THE FOLLOWING INFO WAS REPORTED, "INCIDENT DATE: 2004; CRANIOTOMY FOR RESECTION OF TUMOR. DURA PATCH GRAFT. FDA RECALL OF GRAFT. SUSPECT STERILIZATION ENVIRONMENT CONTROL FAILURE. I&D OF POST OP INFECTION." ADDITIONAL INFO OBTAINED: A REVIEW OF THE COMPLAINT DATABASE FROM 10/01/2004 TO PRESENT DOES NOT INDICATE THE INTEGRA WAS AWARE OF THE INCIDENT. AN INTEGRA REP SPOKE TO THE REP FROM THE USER FACILITY ON 10/29/07 TO OBTAIN ADDITIONAL INFO AND A COPY OF THE MEDWATCH FILED. THE USER FACILITY DID NOT RETAIN A COPY OF THE MEDWATCH IN THEIR FILES. THE REP AT THE USER FACILITY STATED THAT THEY CANNOT IMPLICATE ENDURA AS THE CAUSE OF THE INCIDENT. THE MEDWATCH FILING WAS THE RESULT OF A VOLUNTARY RECALL AND NOT DUE TO THE HEALTH PROFESSIONAL OR PT REPORTING THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURA NO-REACT DURAL SUBSTITUTE 6CM X 10CM ENDURA GXQ SHELHIGH INC * 040303NRD

    Patients

    Seq Age Sex Outcome Treatment
    1 *