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

Catalog Number	202050
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 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, the device history record (dhr) was reviewed, and no anomalies were found, and proper finished good testing was performed prior to release as indicated in the dhr.The root cause is undetermined issue 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.At present, we consider this complaint to be closed.
Event or Problem Description
An authorized distributor reported that duraseal dural sealant system 5ml us box of 5 (202050) could not turn into hydrogel formation during surgery while in contact with the patient.There was no injury or surgical delay.
Additional Manufacturer Narrative
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 include syringes (phosphate/borate) and 1 vial with vial adapter.Both syringes were visually inspected, and no damage have been detected.However, both syringes were received empty and with marks of blue solution outside, and the borate syringe also had a loose syringe cap.The vial was received with the vial adapter, no damage was detected but a residue of blue solution was observed outside, and remaining solution can be observed into the vial which was still in liquid state.After sample evaluation, the failure mode could not be confirmed, and the sample remains were not enough to try and reproduce the failure mode.Root cause - the root cause is undetermined because product was received for testing and the failure mode reported was not confirmed.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.

• 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: 24546659
• Report Number: 3003418325-2026-00009
• Device Sequence Number: 17536126
• 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): 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 Expiration Date: 04/30/2026
• Device Catalogue Number: 202050
• Device Lot Number: 60685975
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• 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