BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN PLUS DURAL REGENERATION MATRIX 1X3 5 PAC

    MDR report key: 21926614 · Received April 29, 2025

    Report

    Report Number
    1121308-2025-00015
    Event Type
    Injury
    Date Received
    April 29, 2025
    Date of Event
    December 16, 2024
    Report Date
    June 16, 2025
    Manufacturer
    INTEGRA - PRINCETON
    Product Code
    GXQ
    UDI-DI
    10381780070924
    PMA / PMN Number
    K032693
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR INCIDENT OCCURRING ON (B)(6) 2024: 1. WHAT REVISION/MEDICAL INTERVENTION WAS PERFORMED AFTER CSF LEAK OCCURRED? ANSWER: HOSPITALIZATION/ LUMBAR DRAIN PLACEMENT. 2. HOW MUCH CSF LEAKED DURING THE INCIDENT (IF AN EXACT AMOUNT CANNOT BE PROVIDED, PLEASE PROVIDE AN APPROXIMATE AMOUNT: SMALL AMOUNT, MODERATE, ETC.)? ANSWER: MODERATE. 3. WAS THE PATIENT MOVED, OR BEING MOVED AT THE TIME OF THE INCIDENT? ANSWER: UNKNOWN. 4. PLEASE PROVIDE PATIENT OUTCOME. ANSWER: EXPECTED OUTCOME FOR WHICH SURGERY WAS PERFORMED. 5. WHAT TYPE OF PROCEDURE WAS DURAGEN USED FOR? ANSWER: SUBOCCIPITAL CRANI FOR MICROVASCULAR DECOMPRESSION. 6. THE TIMEFRAME OF IMPLANT DATE TO INCIDENT DATE. ANSWER: UNKNOWN. 7. DETAILS SURROUNDING THE INTRA-OPERATIVE PROCEDURE. ANSWER: THE MICROSCOPE WAS REMOVED; THE DURA WAS REAPPROXIMATED WITH INTERRUPTED 4-0 NUROLON. THIS WAS COVERED WITH A SMALL DURAGEN. WE THEN RELAXED ALL THE BONE EDGES. THE CRANIOTOMY WAS NOW PLATED ON A LARGE BUR HOLE COVER AND A DOG BONE AND THE EFFECTS OF THE SKULL USING TITANIUM SCREWS. WE THEN PLACED ADVASEAL OVER THE BUR HOLE COVER, SPARING THE AC WENT THROUGH THE GAPS. THE RETRACTOR WAS NOW REMOVED. METICULOUS HEMOSTASIS WAS OBTAINED WITH BIPOLAR CAUTERY AND IRRIGATION. THEN CLOSED THE SCALP IN LAYERED FASHION. 8. SURGICAL TECHNIQUE (STERILE, DOCUMENTED SURGICAL CLASS AS CLEAN PROCEDURE). 9. ANY CONCOMITANT DEVICES (I.E. SURGICAL SEALANTS) USED. ANSWER: VISTASEAL. INVESTIGATION FINDINGS: DURAGEN PLUS DURAL REGENERATION MATRIX (DP5013) WAS NOT RETURNED FOR EVALUATION FOR THE UNITS INVOLVED IN THE SIX (6) CASES REPORTED. ACCORDING TO THE COMPLAINT INFORMATION NO PRODUCT WILL BE RETURNED AND THE PRODUCT WITH THE SAME LOT NUMBER WAS REMOVED FROM CIRCULATION. ALSO, NO PHOTO SHOWING THE REPORTED CONDITION AND/OR PRODUCT WAS PROVIDED; THUS, THE REPORTED LOT NUMBER CANNOT BE CONFIRMED EITHER. HOWEVER, AN INVESTIGATION OF RETAINED SAMPLES WAS PERFORMED: DEVICE HISTORY RECORD (DHR) REVIEW - THE DHR WAS REVIEWED, AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING AND PACKAGING PROCESS THAT COULD BE RELATED TO THE REPORTED CONDITION. RETAINED SAMPLE FAILURE ANALYSIS - FIVE (5) UNITS WERE VISUALLY INSPECTED. THE DISPENSER BOX AND CONTENTS WERE IN GOOD CONDITION, TRAY SEALING AREA WAS COMPLETE IN EACH UNIT, NO DEFECTS WERE OBSERVED ON ANY OF THE FIVE (5) SPONGES, AND NO FOREIGN MATERIAL PRESENCE WAS OBSERVED. RETAINED SAMPLE MEDICAL ASSESSMENT - A MEDICAL ASSESSMENT WAS PERFORMED TO EVALUATE THE POSSIBLE RELATION BETWEEN THE REPORTED EVENT AND PRODUCT USE AND CONCLUDES AS FOLLOWS: ¿THERE IS INSUFFICIENT INFORMATION TO CONCLUDE WHETHER THE REPORTED ADVERSE EVENT OF CEREBROSPINAL FLUID (CSF) LEAK POST-SURGERY WAS DUE TO THE DURAGEN PLUS. THE REPORTED COMPLAINTS LACK DETAILED PATIENT AND EVENT INFORMATION, INCLUDING THE TIMEFRAME OF IMPLANT DATE TO INCIDENT DATE, PATIENT¿S RELEVANT MEDICAL HISTORY, DETAILS SURROUNDING THE INTRA-OPERATIVE PROCEDURE, SURGICAL TECHNIQUE, AND ANY CONCOMITANT DEVICES (I.E. SURGICAL SEALANTS) USED. FURTHER INFORMATION HAS BEEN REQUESTED BY THE COMPLAINTS DEPARTMENT BUT TO DATE, NO ADDITIONAL RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER.¿ RETAINED SAMPLE ROOT CAUSE - BASED ON THE AVAILABLE INFORMATION, THERE IS INSUFFICIENT INFORMATION TO CONCLUDE WHETHER THE REPORTED ADVERSE EVENTS OF CEREBROSPINAL FLUID (CSF) LEAK POST-SURGERY WERE DUE TO THE DURAGEN PLUS. ALL REPORTS ARE FROM A COMMON SOURCE WHICH MAY SUGGEST THAT THE SITUATION MAY BE TECHNIQUE AND/OR USER RELATED. FOR NOW, INTEGRA WILL CONTINUE TO MONITOR FOR POSSIBLE RECURRENCE FOR TRENDING PURPOSES AND TO EVALUATE IF ANY ACTIONS ARE REQUIRED IN THE FUTURE. 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

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS 1121308-2025-00016 AND 1121308-2025-00017: A FACILITY REPORTED THAT DURA LEAKS (CSF LEAKAGE) WITH THE SAME LOT NUMBER OF THE DURAGEN PLUS DURAL REGENERATION MATRIX (DP5013) OCCURRED POST-SURGERY. NO, POST-OPERATION COMPLICATION OCCURRED AFTER THE PROCEDURE (LINKED TO THE SAME LOT NUMBER), AND NO DURAGEN HAS BEEN REMOVED FROM PATIENTS. HOWEVER, DURAGEN PRODUCTS WITH THE SAME LOT NUMBER HAS BEEN REMOVED FROM CIRCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463332 DURAGEN PLUS DURAL REGENERATION MATRIX 1X3 5 PAC N/A GXQ INTEGRA - PRINCETON 7377759 10381780070924

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other VISTASEAL.