BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5

    MDR report key: 21942454 · Received May 1, 2025

    Report

    Report Number
    3003418325-2025-00015
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    March 12, 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

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H11. DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) WAS NOT RETURNED FOR ANALYSIS AND THE INVESTIGATION COULD NOT CONFIRM THE COMPLAINT. A 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: ISSUES WITH PERFORMANCE. 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.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT DURING "POSTERIOR LUMBAR INTERBODY FUSION" PROCEDURE, THE DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) SOLUTION LEAKED OUT AND COULD NOT BE USED WHILE BEING INJECTED INTO THE POWDER VIAL. THE PROBLEM OCCURRED DURING THE PROCESS OF DILUTING THE POWDER AND SOLUTION AND DID NOT COME IN CONTACT WITH THE PATIENT. SURGERY WAS DELAYED FOR THE MOMENT, BUT IT WAS SUCCESSFULLY COMPLETED DUE TO THE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934836 DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 DURASEAL CRANIAL NQR INTEGRA - PRINCETON 60494441 10381780000020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown