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

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	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that following the powder mixing and installation of duraseal dural sealant system 5ml (202050), an uneven distribution of the solution was observed.Coagulation is suspected; however, the exact cause remains unidentified as the application occurred within 20 minutes of preparation.No errors were noted during the mixing procedure, and despite aligning the syringe levels, the uneven spray pattern continued to occur.There was a delay of 10 minutes; however, no patient injury occurred.
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.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The duraseal dural sealant system (202050) was returned for evaluation: device history record (dhr) - 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.Failure analysis - investigation showed that the sample received back included 1 open pouch inside the poly bag, and 1 kit assembly (2 syringes and 1 y-connector).The clear syringe was observed without solution and connected to the y-connector.The clear syringe was disconnected from the y-connector, and no damage was observed in the barrel nor in the tip.The black rubber tip was removed from the gray plunger, and it was confirmed that the black rubber tip is a kokoku tip.The blue syringe was observed without solution and connected to the y-connector and with traces of blue solution near the tip.The blue syringe was disconnected from the y-connector, and it was pressed to obtain the material inside which had a jelled consistency.It was also confirmed that the black rubber tip is a kokoku tip.With the sample available, the failure mode was confirmed since there was gelled material in the blue syringe.Root cause - after sample evaluation, the failure mode is confirmed; however, the root cause is undetermined.Per the dfmea, potential causes of failure include: issues with solution mixing and coverage.The complaint will be closed as could not be reliably determined, and the risk remains acceptable per the risk analysis.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.Additional information: subsequent information has been received advising that the device was not in contact with the patient.Investigation narrative: 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: solution mixing and coverage.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 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.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Common Device Name: DURAL REPAIR
• 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: 24279478
• Report Number: 3003418325-2026-00003
• Device Sequence Number: 12906476
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026

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: 60545276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/13/2026; 03/23/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 02/20/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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