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

Catalog Number 206520

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2023

Event Type  malfunction  

Event Description

A facility reported that during spine surgery, despite proper and diligent mixing, when duraseal exact spine sealant system 5ml us box of 5 (206520) was sprayed, it came out in clump form.This made it unusable for procedure.The product was in contact with the patient; however, no injury or surgical delay occurred.

Manufacturer Narrative

The duraseal exact spine sealant system 5ml us box of 5 (206520) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause is undetermined, and the complaint was unable to be confirmed with the information available.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.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
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18283847
• MDR Text Key: 329952093
• Report Number: 3003418325-2023-00019
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• PMA/PMN Number: P080013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 206520
• Device Lot Number: 60407873
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/07/2023
• Date Device Manufactured: 10/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1