BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN PLUS ADHESION BARRIER MATRIX 2X2, 5 PACK

    MDR report key: 5953692 · Received September 15, 2016

    Report

    Report Number
    1121308-2016-00018
    Event Type
    Injury
    Date Received
    September 15, 2016
    Date of Event
    August 22, 2016
    Report Date
    August 30, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    PMA / PMN Number
    K032693
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 05 OCT 2016. METHOD: RETAINED SAMPLES VISUAL EVALUATION. DHR REVIEW. REVIEW OF COMPLAINT HISTORY. THE UNIT WAS NOT RETURNED FOR EVALUATION SINCE THE UNIT WAS IMPLANTED IN THE PATIENT. FIVE (5) RETAIN SAMPLES OF FG LOT 1153627 WERE VISUALLY EVALUATED FOR PRODUCT AND PACKAGING APPEARANCE TO CONFIRM NO DETERIORATION. NO SIGNS OF DETERIORATION WERE FOUND DURING THE RETAIN SAMPLE VISUAL EVALUATION. DEVICE HISTORY RECORD OF THE FINISHED GOOD (FG) LOT # 1153627 WAS REVIEWED AND COMPLETED ON 09/29/2016. FINISHED GOODS (FG) LOT 1153627 ORIGINATES FROM (B)(4) AT LOTS 105000307563 AND 105000311562; THAT WERE THEN TRANSFERRED TO (B)(4) FACILITY FOR FURTHER PROCESSING. ALL DOCUMENTATION AND IN PROCESS TESTING WERE FOUND TO MEET THE SPECIFIED REQUIREMENTS. BACTERIAL ENDOTOXIN AND BIOBURDEN RESULTS MET ALL REQUIREMENTS AND WERE FOUND TO BE ACCEPTABLE PER THE IN-PROCESS RELEASE SPECIFICATIONS IT WAS CONCLUDED, AS A RESULT OF THIS REVIEW THAT THE MANUFACTURING PROCESS OF AT LOTS 105000307563 AND 105000311562 AT (B)(4) FACILITY MET ALL MANUFACTURING AND TESTING REQUIREMENTS AS DEFINED IN THE SPECIFIED PROCEDURES. NO SIMILAR COMPLAINTS RELATED TO ¿CSF LEAK¿ HAVE BEEN REPORTED FOR THIS FG LOT 1153627. UPON REVIEW OF INTEGRA¿S COMPLAINT SYSTEM FROM AUGUST 2014 TO AUGUST 2016 TOTAL OF FIVE (5) COMPLAINTS (INCLUDING THIS COMPLAINT) RELATED TO ¿CSF LEAK¿ FOR DURAL REPAIR DURAGEN PRODUCT FAMILY HAVE BEEN REPORTED. (B)(4). CONCLUSION: NO CHANGES TO THE ORIGINAL CONCLUSIONS ARE NECESSARY AS RESULT OF THIS DRH REVIEW. BASED ON INTEGRA¿S MEDICAL AFFAIRS INSIGHT CHIARI DECOMPRESSION AND POSTERIOR FOSSA SURGERY ARE CHALLENGING PROCEDURES ASSOCIATED WITH HIGH RATES OF COMPLICATIONS INCLUDING CSF LEAK. IN A RETROSPECTIVE REVIEW OF 500 PATIENTS UNDERGOING POSTERIOR FOSSA SURGERY¿ LOOKING AT THE 60 CHIARI DECOMPRESSION PATIENTS IN THIS STUDY, 18% EXPERIENCED A CSF LEAK. CONSEQUENTLY, A CSF LEAK IN CHIARI PATIENT IS NOT AN UNEXPECTED ADVERSE EVENT. ACCORDING TO THE DEVICE HISTORY RECORD REVIEWS OF AT LOTS 105000307563, 105000311562, REPORTED FINISHED GOODS LOT 1153627 AND THE MEDICAL AFFAIRS INSIGHT, THE CONDITION IS NOT CONFIRMED TO BE RELATED TO DURAGEN PLUS ADHESION BARRIER MATRIX 2X2, 5PK, CATALOG DP5022I.

    Description of Event or Problem · 1

    CEREBROSPINAL FLUID (CSF) LEAKAGE AFTER IMPLANTATION OF DEVICE WAS REPORTED ON A 4 YEAR OLD FEMALE PATIENT WHO UNDERWENT A POSTERIOR FOSSA SURGERY FOR A CHIARI MALFORMATION TYPE II ON (B)(6) 2016. DURAGEN AND DURASEAL WERE REPORTED TO BE USED FOR THE SURGERY. THE CSF LEAK STARTED 8 DAYS AFTER THE SURGERY. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2016 AND HAD THE SECOND SURGERY ON (B)(6) 2016. THE SURGEON COMMENTED THAT THE "MATRIX WAS LIKE DISINTEGRATED, WITH A LACK OF CONFORMABILITY. THE SURGICAL SITE WAS DRY BEFORE THE APPLICATION OF THE PRODUCT". PATIENT IS STILL CURRENTLY AT THE HOSPITAL UNTIL HER COMPLETE RECOVERY. ADDITIONAL INFORMATION RECEIVED ON 02SEP2016 WITH THE FOLLOWING FROM THE DISTRIBUTOR: DURAGEN PLUS WAS BEING USED. NO COMPANY TECHNICIAN WAS PRESENT AT THIS SURGERY BECAUSE THE SURGEON WAS SUPPOSEDLY TRAINED DURING THE WORKSHOP ORGANIZED AND HE JUST ASKED TO AVAIL ABLE THE PRODUCT FOR HIM. DURAGEN WAS CONSIDERED TO BE EASY TO APPLY. WITH REGARDS TO THE DURASEAL, THE SURGEON WAS TRAINED ON THE ASSEMBLY. THE SAFETY MARGIN OF 1CM AT LEAST WAS RESPECTED UPON APPLYING THE DURAGEN ACCORDING TO THE SURGEON. THE DISTRIBUTOR STATED THEY WILL RECOMMEND FROM NOW ON THE SUTURABLE VERSION FOR POSTERIOR FOSSA. IT WAS THE FIRST TIME HE USED DURAGEN BUT HE USED OTHER PRODUCTS BEFORE. IN THE SECOND OPERATION, NO PRODUCT WAS USED; ONLY AUTOLOGOUS GRAFT. ACCORDING TO THE SURGEON, THE MATRIX DID NOT ADHERE NOR FORM A TIGHT CLOSURE. ADDITIONAL INFORMATION RECEIVED ON 10SEP2016 FROM THE DISTRIBUTOR: "THE PATIENT IS GOOD NOW , AFTER THE SECOND SURGERY (WE PUT AUTOGRAFT)" LINKED TO MFG. REPORT NUMBER: 3003418325-2016-00024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606533 DURAGEN PLUS ADHESION BARRIER MATRIX 2X2, 5 PACK N/A GXQ INTEGRA LIFESCIENCES CORPORATION 1153627

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention