BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN DURAL GRAFT MATRIX

    MDR report key: 13966008 · Received March 31, 2022

    Report

    Report Number
    1121308-2022-00027
    Event Type
    Injury
    Date Received
    March 31, 2022
    Report Date
    February 14, 2023
    Manufacturer
    INTEGRA - PRINCETON
    Product Code
    GXQ
    PMA / PMN Number
    K982180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURAGEN DURAL GRAFT MATRIX (DURAGEN) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THERE IS NO CLINICAL INFORMATION OF THE REPORTED CSF LEAKS; ALSO, IT IS UNCLEAR HOW MANY OF THE TWO (2) REPORTED CSF LEAKS INVOLVED THE USE OF DURAGEN. DUE TO LACK OF INFORMATION AND/OR SAMPLES TO EVALUATE, A ROOT CAUSE DETERMINATION IS NOT POSSIBLE. ADDITIONALLY, THE INSTRUCTIONS FOR USE (IFU) ADDRESSES POSSIBLE COMPLICATIONS THAT CAN OCCUR WITH ANY NEUROSURGICAL PROCEDURE SUCH AS "CEREBROSPINAL FLUID LEAKS, INFECTION, DELAYED HEMORRHAGE, AND ADHESION FORMATION." IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELD: H6 (MEDICAL DEVICE PROBLEM CODE). THIS MDR IS BEING SUBMITTED FOR CORRECTION OF A CODING ERROR IN H6 FIELD (MEDICAL DEVICE PROBLEM CODE SELECTED SHOULD HAVE BEEN 2993).

    Description of Event or Problem · 0

    THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 1121308-2022-00026: THIS REPORT IS FROM SUBJECT OF SPEECH AT (B)(6) NEUROSURGICAL SOCIETY HELD ON (B)(6) 2022 TITLED: " CHANGES IN RECONSTRUCTIVE SURGERY AFTER ENDOSCOPIC TRANSSPHENOIDAL SURGERY BEFORE AND AFTER THE INTRODUCTION OF DURAGEN-REDUCTION IN PEDICLE-FREE TISSUE COLLECTION." IT WAS REPORTED THAT TWO (2) CASES OF POSTOPERATIVE CEREBROSPINAL FLUID (CSF) LEAK WERE OBSERVED. OF THE 280 CASES OF TRANSNASAL ENDOSCOPIC SURGERY PERFORMED AT (B)(6) HOSPITAL FROM JANUARY 2015 TO SEPTEMBER 2021, 238 CASES EXCLUDING INTRAORBITAL LESIONS, EXTENSIVE SKULL BASE SURGERY AND COMBINED SURGERY WITH A MICROSCOPE EXAMINATION. TWO (2) GROUPS WERE DIVIDED BEFORE DECEMBER 2019 WHEN DURAGEN WAS STARTED. THE FIRST HALF GROUP (159 CASES) AND THE SECOND GROUP (77 CASES), POSTOPERATIVE CSF LEAKAGE OCCURRED IN TWO CASES. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345685 DURAGEN DURAL GRAFT MATRIX N/A GXQ INTEGRA - PRINCETON

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown