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

Catalog Number	206520
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An authorized distributor reported that during spine tumor surgery, duraseal exact spine sealant system 5ml (206520) could not turn into hydrogel formation while in contact with the patient.There was no patient injury or surgical delay.User facility: (b)(6).
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
N/a.
Additional Manufacturer Narrative
Updated field: d9, g3, g6, h2, h3, h6, h11.The duraseal exact spine sealant system 5ml us box of 5 (206520) was subsequently 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 open pouch inside the polybag and 1 kit assembly (2 holders, 2 syringes, and 1 y-connector).The kit was disassembled to verify the components, syringe holder and plunger cap were without damage.The y-connector was visually inspected, no damage was on top of it, but blue traces were observed in the side where the blue syringe was connected.Clear syringe and blue syringe were empty; no damage was observed in the body nor in the tip of the syringes.When the plunger was removed from the blue syringe, a trace of blue solution was detected in the black rubber, and it looked completely dry.There was not enough material to check the condition and reaction of the solution, and in the blue syringe there was dry material detected which indicates that the material was reconstituted.As a result, the failure mode is not confirmed.Root cause - the root cause is undetermined because product was received for testing and the failure mode could not be confirmed.Per the dfmea, potential causes of failure include ¿issues with 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Duraseal exact spine sealant system 5ml us box of 5 (206520) was not returned for analysis.Lot number information was provided; therefore, only a dhr review could be performed.At the time of manufacturing, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications.Proper finished good testing was performed prior to release as indicated in the dhr.Due to no product return, the root cause is undetermined and was unable to be confirmed in the complaint evaluation.Per the dfmea, potential causes of failure include: issues with solution mixing and coverage.The risk remains acceptable per the risk analysis, and no enhancements or improvements were generated for the reported condition.The complaint will be closed as could not be reliably determined, and trends will be monitored for this and similar issues.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.

• Brand Name: DURASEAL EXACT SPINE 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: 24405685
• Report Number: 3003418325-2026-00006
• Device Sequence Number: 8223314
• Product Code: NQR
• UDI-Device Identifier: 10381780000044
• UDI-Public: 10381780000044
• Combination Product (Y/N): N
• PMA/510(K) Number: P080013
• 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,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: 06/30/2026
• Device Catalogue Number: 206520
• Device Lot Number: 60653821
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/03/2026; 03/23/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/20/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2025
• 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