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

Catalog Number	202050
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.Duraseal dural sealant system (202050) was not returned for analysis; therefore, evaluation of the product is not possible.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Per the fmea, potential causes of failure include solution mixing and coverage.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.At present, we consider this complaint to be closed.If additional information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.
Event or Problem Description
N/a.
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
A facility reported that during the surgical procedure of a patient diagnosed with a skull base tumor, duraseal dural sealant system (202050) was correctly prepared, and 5 ml of duraseal was applied.However, the texture was not normal, but rather viscous.The specialist decided to aspirate it, since he mentioned that it should be otherwise.To complete the surgery, the specialist did not use any other product and decided to close it.There was no patient injury or delay in surgery due to the product problem.

• 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: 22612519
• Report Number: 3003418325-2025-00047
• Device Sequence Number: 21217229
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 202050
• Device Lot Number: 60526555
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2024
• 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
• Patient Sex: Unknown