MAUDE Adverse Event Report: INTEGRA - PRINCETON DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5; DURASEAL CRANIAL

Catalog Number	202050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
This report is 1 of 2 and linked to mfg report number: 1121308-2025-00022: a facility reported that a patient diagnosed with subdural hematoma underwent surgery on (b)(6) 2025.However, in the following days, he developed a fistula that required reoperation.The reoperation was performed to treat the aforementioned complication.The same product references were used in the second surgery, and the patient is in stable condition.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The 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: performance and adhesion barrier.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.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Common Device Name: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ 08540
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22385700
• Report Number: 3003418325-2025-00032
• Device Sequence Number: 20577746
• Product Code: NQR
• UDI-Device Identifier: 10381780000020
• UDI-Public: 10381780000020
• Combination Product (Y/N): N
• PMA/510(K) Number: P040034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 202050
• Device Lot Number: 60548845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DURAGEN SUTURABLE ((B)(6)).
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male