BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 3

    MDR report key: 5314339 · Received December 21, 2015

    Report

    Report Number
    1121308-2015-00040
    Event Type
    Injury
    Date Received
    December 21, 2015
    Date of Event
    December 2, 2015
    Report Date
    December 3, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    PMA / PMN Number
    K043427
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 3/17/2016. THE UNIT WAS NOT RETURNED FOR EVALUATION SINCE THE UNIT WAS IMPLANTED IN THE PATIENT. ONE (1) RETAIN SAMPLE OF FG LOT 1151696 WAS VISUALLY EVALUATED FOR PRODUCT AND PACKAGING APPEARANCE TO CONFIRM NO DETERIORATION. NO SIGNS OF DETERIORATION WERE FOUND DURING THE RETAIN SAMPLE VISUAL EVALUATION. DHR REVIEW REVEALED NO ANOMALIES WERE REPORTED DURING THE MANUFACTURING AND PACKAGING PROCESSES OF THIS LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. A TOTAL OF TWO (2) COMPLAINTS (INCLUDING THIS ONE) HAVE BEEN REPORTED FOR FINISHED GOODS (FG) LOT 1151696. FIVE (5) COMPLAINTS (INCLUDING THIS ONE) HAS BEEN REPORTED RELATED TO DURAGEN ¿CSF LEAKAGE¿ AT INTEGRA LIFESCIENCES (B)(4) FACILITY SINCE DECEMBER 2013. COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). BASED ON INTEGRA¿S MEDICAL AFFAIRS ASSESSMENT, CSF LEAK IS NOT AN UNEXPECTED ADVERSE EVENT (AE) AS STATED IN THE IFU. WITHOUT ABNORMALITIES FOUND IN THE PRODUCT LOT AND WITHOUT DEVICE RETURNED FOR INVESTIGATION, A CAUSE FOR THIS PARTICULAR PATTERN OF CSF LEAK IS LIKELY RELATED TO THE FOLLOWING EXPLANATION PROVIDED BY INTEGRA CHIEF SCIENTIFIC OFFICER: CELLS MIGRATE AT APPROXIMATELY 1 MM PER DAY, SO DEPENDING ON THE SIZE OF THE GRAFT THERE WILL BE A GREATER OR SMALLER REGION OF POROUS MATRIX IN THE CENTER OF THE GRAFT. THE MATRIX LOSES THE FIBRIN CLOT SEAL THAT IS NOT SUBSTITUTED BY THE CELLULAR CLOSURE AND SO ONE GETS AN ¿OOZING¿ OF CSF THROUGH THE CENTER OF THE GRAFT.

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED A CEREBROSPINAL FLUID (CSF) LEAK POST-OP AFTER THE (B)(6) 2015 SURGERY. ON (B)(6) 2015, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) AND A LEAK WAS FOUND AT THE EDGE OF THE DURAL REPAIR (WHICH THE NEUROSURGEON REPORTED WAS NORMAL, TYPICAL, AND EXPECTED.) THIS CLOSED PROPERLY WITH A SUTURE. THE NEUROSURGEON STATED THE "ODD THING WAS THE CSF SEEMED TO BE OOZING THROUGH THE ENTIRE SURFACE OF THE DURAGEN, AS IF IT WAS POROUS. THIS I HAVE NOT SEEN BEFORE AND IT WAS CONCERNING." THE OOZING DID SEEM TO STOP WHEN AN OVERLAYED DURAGEN PLUS WAS PLACED OVER THE SUTURABLE PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839269 DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 3 N/A GXQ INTEGRA LIFESCIENCES CORPORATION 1151696

    Patients

    Seq Age Sex Outcome Treatment
    1 Other