BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5

    MDR report key: 22549268 · Received July 18, 2025

    Report

    Report Number
    3003418325-2025-00037
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    May 2, 2025
    Report Date
    August 25, 2025
    Manufacturer
    INTEGRA - PRINCETON
    Product Code
    NQR
    UDI-DI
    10381780000044
    PMA / PMN Number
    P080013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER
    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, H6, H11. ADDITIONAL INFORMATION RECEIVED: 1. PLEASE ADVISE THE TYPE OF INFECTION/ORGANISM IF KNOWN. ¿ CRANIOTOMY DEEP SURGICAL SITE INFECTION, ORGANISM CUTIBACTERIUM ACNES ¿ CRANIOTOMY DEEP SURGICAL SITE INFECTION, ORGANISM CUTIBACTERIUM ACNES, STAPHYLOCOCCUS COAG NEGATIVE, STAPHYLOCOCCUS LUGDUNENSIS ¿ CRANIOTOMY DEEP SURGICAL SITE INFECTION, ORGANISM STAPHYLOCOCCUS AUREUS ¿ CRANIOTOMY ORGAN SPACE SURGICAL SITE INFECTION, ORGANISM CUTIBACTERIUM ACNES. 2. WHAT TESTS WERE DONE TO CONFIRM THE INFECTION IN THE PATIENT? ¿ ORGANISM IDENTIFIED FROM FLUID OR TISSUE IN THE DEEP AND/OR ORGAN SPACE BY CULTURE OR NON-CULTURED MICROBIOLOGIC TESTING ¿ PHYSICIAN ASSESSMENT THAT MAY INCLUDE GROSS ANATOMICAL EXAM, HISTOPATHOLOGIC EXAM AND/OR IMAGING TEST ¿ SURGICAL SITE INFECTION IN-DEPTH REVIEW BY AN INFECTION PREVENTIONIST. 3. WHAT TREATMENT AND OR MEDICATION WAS GIVEN FOR THE INFECTION ¿ IF MEDICATIONS WERE ADMINISTERED, PLEASE INCLUDE MEDICATION NAMES. ¿ I DO NOT HAVE ACCESS TO PROVIDER TO PATIENT TREATMENT PLANS OR OUTCOMES. 4. PLEASE ADVISE IF ANY OTHER MEDICAL/SURGICAL INTERVENTION WAS ADMINISTERED. ¿ I DO NOT HAVE ACCESS TO PROVIDER TO PATIENT TREATMENT PLANS OR OUTCOMES. 5. WHAT IS THE HEALTH HISTORY OF THE PATIENT? ¿ 3 PATIENTS ARE CLINICALLY OBESE, AND 1 HAD DIABETES. 6. PLEASE ADVISE OF THE PATIENT¿S OUTCOME AND/OR STATUS REGARDING THE INFECTION. ¿ I DO NOT HAVE ACCESS TO PROVIDER TO PATIENT TREATMENT PLANS OR OUTCOMES. A NOTABLE FINDING WAS THAT OUR MICROBIOLOGY DEPARTMENT CULTURED SEVERAL STERILE UNUSED/UNOPENED PRODUCTS THAT HAD BEEN PULLED FROM SERVICE. ONE OF THE CULTURES RESULTED IN: ORGANISM CUTIBACTERIUM ACNES. INVESTIGATION FINDINGS: THE DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5 (206520) WAS NOT RETURNED FOR ANALYSIS. LOT NUMBER INFORMATION WAS PROVIDED; THEREFORE, ONLY A DHR REVIEW COULD BE PERFORMED. AT THE TIME OF MANUFACTURING, RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS. THE DHR REVIEW CONFIRMED THE FINISHED GOOD FOR THE WORK ORDER WAS PROCESSED WITHIN QUALIFIED PARAMETERS AND PASSED THE REQUIRED INSPECTION CHECKS, INCLUDING ENDOTOXIN AND CYTOTOXICITY WHICH SATISFACTORILY MET THE REQUIREMENTS. DUE TO NO PRODUCT RETURN, THE ROOT CAUSE IS UNDETERMINED AND WAS UNABLE TO BE CONFIRMED IN THE COMPLAINT EVALUATION. PER THE FMEA, POTENTIAL CAUSES OF FAILURE INCLUDE: BIOCOMPATIBILITY. THE RISK REMAINS ACCEPTABLE PER THE RISK ANALYSIS. NO ENHANCEMENTS OR IMPROVEMENTS WERE GENERATED FOR THE REPORTED CONDITION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    THIS REPORT IS 2 OF 2 LINKED TO MFG REPORT NUMBER: 3003418325-2025-00043: MEDWATCH "MDR REPORT#: MW5171416" WAS RECEIVED WITH THE FOLLOWING INFORMATION: "SURGICAL SITE INFECTION. SUBOCCIPITAL CRANIOTOMY AND C1 LAMINECTOMY FOR RESECTION OF 4TH VENTRICAL BRAIN TUMOR. PROCEDURE DONE BY DR. (B)(6) AND DR. (B)(6). DURASEAL WAS USED BUT THE MICROMYST APPLICATOR WAS ALSO USED IN ADDITION. REF REPORT: MW5171416." ADDITIONAL INFORMATION IS BEING REQUESTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574750 DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5 DURASEAL SPINE NQR INTEGRA - PRINCETON 60633548 10381780000044

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other MICROMYST APPLICATOR.