BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5

    MDR report key: 21986618 · Received May 8, 2025

    Report

    Report Number
    3003418325-2025-00017
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 9, 2025
    Report Date
    June 16, 2025
    Manufacturer
    INTEGRA - PRINCETON
    Product Code
    NQR
    UDI-DI
    10381780000020
    PMA / PMN Number
    P040034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) WAS NOT RETURNED FOR ANALYSIS AND THE INVESTIGATION COULD NOT CONFIRM THE COMPLAINT. A DEVICE HISTORY RECORD (DHR) REVIEW AND TRENDING WERE PERFORMED AS PART OF THE EVALUATION. PROPER FINISHED GOOD TESTING WAS PERFORMED PRIOR TO RELEASE AS INDICATED IN THE DHR. THE ROOT CAUSE IS UNDETERMINED AND WAS UNABLE TO BE CONFIRMED IN THE COMPLAINT EVALUATION. PER THE FMEA, POTENTIAL CAUSES OF FAILURE INCLUDE: SOLUTION MIXING AND COVERAGE. THE RISK REMAINS ACCEPTABLE PER THE RISK ANALYSIS. NO ENHANCEMENTS OR IMPROVEMENTS WERE GENERATED FOR THE REPORTED CONDITION. THE FILE WILL BE CLOSED AS COULD NOT BE RELIABLY DETERMINED. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED, AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. 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

    A FACILITY REPORTED THAT DURING "LEFT PARIETAL METASTATIC LESION, POSTOPERATIVE RESECTION OF LEFT PARIETAL LESION BY NEURO-NAVIGATION-GUIDED CRANIOTOMY" PROCEDURE, A PATCH WAS PLACED AND WHEN DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) WAS APPLIED IT CAME OUT LIQUID AND DID NOT ADHERE. ANOTHER PRODUCT FROM ANOTHER COMMERCIAL BRAND WAS USED TO COMPLETE THE SURGICAL PROCEDURE. THERE WAS A DELAY IN SURGERY, HOWEVER, NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS DISCHARGED STABLE WITH RECOMMENDATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034078 DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 DURASEAL CRANIAL NQR INTEGRA - PRINCETON 60548845 10381780000020

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female