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	02/07/2025
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 while in contact with a patient, the duraseal exact spine sealant system (206520) did not turn into hydrogel form.No patient injury or surgical delay has been reported.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The duraseal exact spine sealant system (206520) was returned for evaluation: device history record (dhr) review - the dhr was reviewed, and no anomalies were found during the manufacturing and packaging process that could be related to the reported condition.Failure analysis - investigation showed that the sample received back included 2 syringes (borate/phosphate), 2 syringe caps (white/blue), 1 syringe holder, 1 y-connector, 2 loose spray tips, and 1 vial.Loose spray tips and y-connector were visually inspected, none of the components were damaged; however, the spray tips and y-connector presented signs of usage.The blue and white syringe caps were also observed without damages.The syringes were received attached to the syringe holder, they were visually inspected and showed no signs of damage.Both syringes were completely empty; however, the blue syringe had traces of blue solution.The syringes were disassembled to observe the traces in the bottom and top of the blue syringe.The traces in the bottom side looked dry and the traces in the top of the syringe were gelled.The vial was observed with the spike fully depressed.The redline was not visible and the vial had traces of blue solution inside and on top of the bioset.The solution inside of the vial appeared to be gelled.With the sample available for evaluation, the failure mode reported could not be confirmed.Root cause - the reported complaint is not confirmed, and the root cause is undetermined.Product received was tested and the failure mode reported was not confirmed.Per the dfmea, potential causes of failure include: issues with solution mixing and coverage.The risk remains acceptable per the risk analysis.

• 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: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21548460
• Report Number: 3003418325-2025-00010
• Device Sequence Number: 8165049
• Product Code: NQR
• UDI-Device Identifier: 10381780537168
• UDI-Public: 10381780537168
• 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
• Report Date (Section B): 03/20/2025

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: 60521863
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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