BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5

    MDR report key: 23213151 · Received October 3, 2025

    Report

    Report Number
    3003418325-2025-00060
    Event Type
    Injury
    Date Received
    October 3, 2025
    Report Date
    March 20, 2026
    Manufacturer
    INTEGRA - PRINCETON
    Product Code
    NQR
    UDI-DI
    10381780000020
    PMA / PMN Number
    P040034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION), H11 (UPDATE TO PREVIOUS MFG NARRATIVE). DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) WAS NOT RECEIVED FOR TESTING; THEREFORE, THE FAILURE MODE COULD NOT BE CONFIRMED. ADDITIONALLY, THE DHR REVIEW WAS UNABLE TO BE PERFORMED AS NO VALID LOT NUMBER WAS REPORTED. AS A RESULT, THE ROOT CAUSE IS UNDETERMINED. PER THE FMEA, POTENTIAL CAUSES OF FAILURE INCLUDE: BIOCOMPATIBILITY. THE RISK REMAINS ACCEPTABLE PER THE RISK ANALYSIS, AND AFTER REVIEW OF HISTORICAL COMPLAINT DATA, NO TREND HAS BEEN IDENTIFIED FOR INFECTION. ADDITIONALLY, MEDICAL SAFETY HAS ALSO REVIEWED THE COMPLAINTS AND CONFIRMED THERE IS NO ADVERSE TREND. AS A RESULT, NO ENHANCEMENTS OR IMPROVEMENTS WERE GENERATED FOR THE REPORTED CONDITION. THE COMPLAINT WILL BE CLOSED AS CANNOT BE RELIABLY DETERMINED. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE REOPENED, 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

    THE DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) WAS NOT WAS NOT RECEIVED FOR TESTING; THEREFORE, THE FAILURE MODE COULD NOT BE CONFIRMED. ADDITIONALLY, THE DHR REVIEW WAS UNABLE TO BE PERFORMED AS NO VALID LOT NUMBER WAS REPORTED. AS A RESULT, THE ROOT CAUSE IS UNDETERMINED. PER THE DFMEA, POTENTIAL CAUSES OF FAILURE INCLUDE: BIOCOMPATIBILITY, AND THE RISK REMAINS ACCEPTABLE PER THE RISK ANALYSIS. NO ENHANCEMENTS OR IMPROVEMENTS WERE GENERATED FOR THE REPORTED CONDITION. THE COMPLAINT WILL BE CLOSED AS COULD NOT BE RELIABLY DETERMINED. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE REOPENED, 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

    N/A.

    Description of Event or Problem · 0

    THIS REPORT IS FOR PATIENT # 2 AND IS RELATED TO MFG REPORT NUMBERS 3003418325-2025-00059 AND 3003418325-2025-00061: A FACILITY REPORTED THAT THEY ARE LOOKING INTO A STRING OF INFECTIONS IN 3 PATIENTS AND MENTIONED THAT ALL 3 PATIENTS ALSO HAD DURASEAL USED DURING THEIR PROCEDURE. THE INFECTIOUS DISEASE PHYSICIAN AT THE FACILITY STATED THAT HE DOESN'T BELIEVE IT HAD ANYTHING TO DO WITH THE INFECTIONS BUT IS JUST TESTING EVERYTHING THAT WAS USED ON EACH PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226718 DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 DURASEAL CRANIAL NQR INTEGRA - PRINCETON 10381780000020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other