BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5

    MDR report key: 18283847 · Received December 7, 2023

    Report

    Report Number
    3003418325-2023-00019
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    October 9, 2023
    Report Date
    December 7, 2023
    Manufacturer
    INTEGRA - PRINCETON
    Product Code
    NQR
    PMA / PMN Number
    P080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5 (206520) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE IS UNDETERMINED, AND THE COMPLAINT WAS UNABLE TO BE CONFIRMED WITH THE INFORMATION AVAILABLE. 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. PER THE DFMEA, POTENTIAL CAUSES OF FAILURE INCLUDE: ISSUES WITH SOLUTION MIXING AND COVERAGE. THE RISK REMAINS ACCEPTABLE PER THE RISK ANALYSIS.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT DURING SPINE SURGERY, DESPITE PROPER AND DILIGENT MIXING, WHEN DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5 (206520) WAS SPRAYED, IT CAME OUT IN CLUMP FORM. THIS MADE IT UNUSABLE FOR PROCEDURE. THE PRODUCT WAS IN CONTACT WITH THE PATIENT; HOWEVER, NO INJURY OR SURGICAL DELAY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258743 DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5 DURASEAL SPINE NQR INTEGRA - PRINCETON 60407873

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown