BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN RM DURAL REGENERATION MATRIX

    MDR report key: 4890699 · Received July 1, 2015

    Report

    Report Number
    1121308-2015-00018
    Event Type
    Injury
    Date Received
    July 1, 2015
    Report Date
    June 8, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    GXQ
    PMA / PMN Number
    K120600
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2015. WOUND INFECTION WITH STAPHYLOCOCCUS AUREUS, ANTIBIOTICS, AND THEN "ANTIBIOSE" WITH SULTAMICILLIN AND CLINDAMYCIN IT WAS THEN SWITCHED TO FLUCLOXACILLIN. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON JULY 24, 2015. THE PRODUCT WAS NOT RETURNED FOR EVALUATION THE PRODUCT WAS IMPLANTED IN THE PATIENT DURING SURGERY. DHR REVIEW MANUFACTURING DATE JUNE 2014, EXPIRATION DATE JUNE 2015. THE NC/EVENT LOG AND BATCH RECORD WERE REVIEWED FOR ANY NCS/EVENTS RELATED TO THE LOTS OF THE COMPONENTS USED TO MANUFACTURE THE PRODUCT THERE WERE NO EVENTS/NCS FOUND. BASED ON THE DHR REVIEW CONDUCTED, THERE IS NO INDICATION THAT THE PRODUCTION PROCESS MAY HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE TRACKWISE COMPLAINT DATABASE FOR THE TIMEFRAME OF (B)(6) 2014 - (B)(6) 2015 (COMPLAINT AWARE DATES) WAS PERFORMED USING THE KEYWORDS "DURAGEN", "INFECTION" AND "FEVER" SIX COMPLAINTS WERE FOUND, INCLUDING THE CURRENT ONE NO TREND WAS IDENTIFIED AT THIS TIME COMPLAINT RATE IS 0 0067 %. THE ROOT CAUSE IS UNDETERMINED SINCE NO PRODUCT WAS RETURNED, THE FAILURE WAS UNCONFIRMED. BASED ON THE DHR REVIEW, TREND ANALYSIS AND THE RISK ASSESSMENT, THERE IS NO INDICATION THAT THE DURAGEN SECURE MANUFACTURING PROCESS IN ANY WAY, ATTRIBUTED TO THIS COMPLAINT. NO REVISION SURGERY WAS NEEDED, THE PATIENT WAS TREATED WITH ANTIBIOTICS. THERE HAVE BEEN NO ADDITIONAL COMPLAINTS OR ISSUES REPORTED WITH THIS PATIENT.

    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

    THIS IS THE FIRST OF TWO REPORTS (SAME PRODUCT FAMILY, SAME USER FACILITY, SAME PHYSICIAN, DIFFERENT PATIENTS). IT WAS REPORTED THAT THE PT WAS IMPLANTED ON (B)(6) 2015 BUT THE PT "PRESENT DAYS AFTER INFECTION/INFLAMMATORY REACTION/MENINGITIS" THAT WERE TREATED BY ANTIBIOTICS. THE SURGEON THINKS IT IS POSSIBLY RELATED TO DURAGEN SECURE. THE PRODUCT WAS STILL IMPLANTED IN THE PT SO NO PRODUCT WILL BE RETURNED. SPECIFIC PRODUCT ID AND LOT NUMBER WERE NOT PROVIDED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426451 DURAGEN RM DURAL REGENERATION MATRIX DURAGEN SECURE GXQ INTEGRA LIFESCIENCES CORP. 105NB0309392

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other| R