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

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	06/19/2025
Type of Reportable Event	Malfunction
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 duraseal exact spine sealant system (206520) was used in the or and did not set up but stayed liquid.Additional information received as follows: 1.What type of procedure was performed during the incident? answer: spine wound exploration i & d.2.Was product in contact with the patient? answer: yes, it was in the contact with the patient, first two failed to thicken up.3.Was there a delay in surgery due to product problem? if yes, how long (in minutes)? answer: yes, it was a delay in the surgery, 10 minutes.4.What action was taken after the product problem occurred (adjustments, replacement, etc.)? answer: additional product was opened until the 3rd kit worked.They belonged to the same lot number.We ordered a new box of five that came in and is on the shelf now.5.Is the product available for evaluation? answer: yes, we have the items from the same lot number available for evaluation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The duraseal exact spine sealant system 5ml us box of 5 (206520) was returned for evaluation: failure analysis - investigation showed that the sample received back included 2 syringes (borate/phosphate), 2 holders, 1 y-connector, 2 loose spray tips and 1 vial.The loose spray tips, y-connector and holders were visually inspected, none of the components were damaged.The spray tips did present signs of usage while the y-connector and holders look unused.Both syringes were visually inspected, no damages were detected, however the borate syringe was apparently used while the phosphate syringe was received empty and with no sign that it was used to withdraw mixing solution from vial was detected.The vial was not received empty, and the solution looked homogeneous, however the mix solidified or dried since it was still stuck on the upper side of the vial.The top of the vial was damaged as well.After sample evaluation, the failure mode could not be observed and components required to complete instructions to form solution in gel were not used.Root cause is also undetermined.Root cause - the root cause is considered undetermined.A dhr review and trending were performed as part of the evaluation.Per the dfmea, potential causes of failure include ¿issues with solution mixing and coverage.¿ the risk remains acceptable per the risk analysis; therefore, 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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.Duraseal exact spine sealant system (206520) was not returned for analysis after three good faith attempts (gfes) and the investigation could not confirm the complaint.As a result, the root cause of the reported issue could not be determined.However, lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.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.

• Brand Name: DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5
• Common Device Name: DURASEAL SPINE
• 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: elizabeth taylor-bowen ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22470627
• Report Number: 3003418325-2025-00035
• Device Sequence Number: 8093921
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2025

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: 206520
• Device Lot Number: 60604503
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 11/05/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/05/2025; 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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