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	Post Operative Wound Infection (2446)
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 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.
Additional Manufacturer Narrative
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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
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.

• 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: 23213151
• Report Number: 3003418325-2025-00060
• Device Sequence Number: 15708005
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2026

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
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 03/04/2026
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 12/05/2025; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown