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	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The duraseal exact spine sealant system 5ml us box of 5 (206520) was returned for evaluation: device history record (dhr) review ¿ a dhr review and trending were performed as part of the evaluation.At the time of manufacturing, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications, and proper finished good testing was performed prior to release as indicated in the dhr.Failure analysis - the sample received back included 2 syringes (borate/phosphate), 2 syringe caps (white/blue), 2 syringe holders, 1 y-connector, 3 loose spray tips, and 1 vial.The loose spray tips, holders and y-connector were visually inspected and the components showed no signs of damage or use.The clear syringe was received full of 2.5 ml of solution, no damages were detected in the body or tip of the syringe.The blue syringe was received with approximately 1.0 ml of solution and no damages were detected in the body or tip of the syringe.Both the white and blue caps were also without damages.The vial was observed with the spike fully depressed, and the redline was not visible.The vial has traces of blue solution inside and on top of the bioset.The solution inside seemed to be gelled with dots of peg not fully dissolved - this could be because the phosphate solution was not completely added.Even though the vial had traces of gelled blue solution, this could be due to time exposed to different conditions.Also, the phosphate solution was not completely used to dissolve the peg as it still had 1.0 ml of solution.As such, with the sample available for evaluation, the failure mode reported could not be confirmed.Root cause - the root cause is undetermined, and the complaint was unable to be confirmed.Product received was tested and no issues were found, nor could the complaint be replicated.Per the afmea, potential causes of failure include: issues with solution mixing and coverage.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
A facility reported that during surgery (spinal tumor), the duraseal exact spine sealant system (206520) could not turn into hydrogel formation.The product was in contact with a patient; however, no patient injury or surgical delay resulted.

• 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: 21621723
• Report Number: 3003418325-2025-00012
• Device Sequence Number: 8510739
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

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
• Date Returned to Manufacturer: 02/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/17/2025
• 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