BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN 4X5 1 PACK CE

    MDR report key: 10277941 · Received July 15, 2020

    Report

    Report Number
    1121308-2020-00004
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    January 27, 2020
    Report Date
    February 26, 2020
    Manufacturer
    INTEGRA LIFESCIENCES CORP
    Product Code
    GXQ
    PMA / PMN Number
    K982180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, THEREFORE THE FAILURE MODE CANNOT BE CONFIRMED. THE DHR REVIEW FOR THE COMPLAINT WAS NOT POSSIBLE SINCE THE LOT NUMBER INVOLVED WAS NOT PROVIDED. MEDICAL AFFAIRS WAS CONTACTED FOR FURTHER EVALUATION. ACCORDING TO MEDICAL AFFAIRS INPUT: ¿SOUNDS LIKE A POST-OP INFECTION WHERE DURAGEN WAS USED IN THE CASE. PROBABLY RELATED TO THE SURGERY ITSELF. COULD BE RELATED TO THE DURAGEN, BUT UNLIKELY.¿. THEREFORE, THE REPORTED CONDITION DESCRIBED AS ¿MENINGITIS¿ COULD NOT BE CONFIRMED. THERE ARE CONTROLS IN PLACE DURING THE PROCESS SUCH AS GOWNING PRACTICES, MANUFACTURING/PACKAGING CONTROLLED-ROOMS (ISO 7), AREA AND PRODUCT MONITORING, AND VALIDATED OVERKILL APPROACH STERILIZATION CYCLES TO PREVENT THIS TYPE OF EVENTS. NO FURTHER EVALUATION IS POSSIBLE; THEREFORE, THE ROOT CAUSE IN UNDETERMINED. BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA PR (B)(4) AND NC 20-011 HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(6), DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(6), ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE REPORTED IN BEHALF OF THE CUSTOMER THAT THE ID4501I DURAGEN 4X5 1 PACK CE WAS USED ON THE PATIENT, THAT LATER DEVELOPED MENINGITIS AFTER THE PROCEDURE. THE DOCTOR PERFORMED CLIPPING TECHNIQUE IN THE SECOND WEEK OF (B)(6) AND DURAGEN WAS USED AT THE TIME OF THE HEAD CLOSURE. AFTER THE OPERATION, CEREBROSPINAL FLUID LEAKAGE DID NOT OCCUR, BUT MENINGITIS (CURRENTLY ONLY FEVER) DEVELOPED 2 WEEKS LATER. THE PATIENT MAY HAVE HAD LOWER IMMUNITY, AND IS CURRENTLY BEING OBSERVED WHILE TAKING VANCOMYCIN. ADDITIONAL INFORMATION RECEIVED ON 28JAN2020 INDICATED THAT THE EVENT OCCURRED ON (B)(6) 2020 TO A FEMALE PATIENT IN HER 50S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743298 DURAGEN 4X5 1 PACK CE N/A GXQ INTEGRA LIFESCIENCES CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR