BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURABLE DURAGEN 3 INCH X 3 INCH INTERNATIONAL

    MDR report key: 10276866 · Received July 15, 2020

    Report

    Report Number
    1121308-2019-00055
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    July 25, 2019
    Report Date
    December 3, 2019
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    GXQ
    PMA / PMN Number
    K043427
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO UNIT WAS RETURNED FOR FAILURE ANALYSIS. EIGHT (8) RETAIN SAMPLES WERE VISUALLY INSPECTED AND A SAMPLE OF THREE (3) UNITS WAS VERIFIED FOR PRODUCT APPEARANCE / DIMENSIONS: ALL RESULTS WERE ACCEPTABLE. THE DEVICE HISTORY RECORD (DHR) OF FG LOT#: 3183268 WAS REVIEWED NO ANOMALY WAS OBSERVED DURING THE MANUFACTURING / PACKAGING PROCESSES. THE COMPLAINT IS UNCONFIRMED. THE ROOT CAUSE IS 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 229048 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.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET 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 PHYSICIAN REPORTED THAT ON (B)(6) 2019, THE DURS3391ITL SUTURABLE DURAGEN 3 INCH X 3 INCH INTERNATIONAL PLACED FOR CLOSING THE DURA MATTER ON A (B)(6) YEAR FEMALE FOR CHIARI MALFORMATION TYPE I, HAD THE FOLLOWING ADVERSE CONSEQUENCES, CSF (CEREBRAL SPINAL FLUID) LEAK ONE WEEK AFTER SURGERY, REQUIRING THE NEED TO PLACE AN EXTERNAL LUMBAR CATHETER. SYMPTOMATIC AND PROGRESSIVE PSEUDOMENINGOCELE AFTER SOME WEEKS, THE REASON FOR A 2ND SURGERY ON (B)(6) 2019. DURING THE 2ND SURGERY THE SURGEON WAS ABLE TO DETERMINE THAT THE CSF WAS GOING THROUGH THE DURAGEN PLACED ON THE 1ST SURGERY (B)(6) 2019, NOT AT THE SEAMS, BUT THROUGH THE DURAGEN. PATIENT WAS REPORTED TO HAVE A LOT OF ORTHOSTATIC HEADACHE FOR 4 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743233 SUTURABLE DURAGEN 3 INCH X 3 INCH INTERNATIONAL N/A GXQ INTEGRA NEUROSCIENCES PR 0000003183268

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR