MAUDE Adverse Event Report: INTEGRA - PRINCETON DURASEAL SPINE OUS 3ML KIT 5KIT/BOX CE APPROVED

Catalog Number 204003

Device Problem Improper Chemical Reaction (2952)

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

Event Date 12/15/2023

Event Type  malfunction  

Event Description

A facility reported that duraseal spine ous 3ml kit 5kit/box ce approved (204003 ) was stored and transported in an ice box, filled with ice packs to maintain low temperature.Product was delivered and well received by facility with instruction to put in a temperature-controlled fridge.One day after the product was received, the physician prepared the duraseal exactly how it was previously done with duraseal 5cc - with the vial pressed, blue solution injected into vial and connected appropriately.However, when duraseal was sprayed over the dura, the spray didn¿t ¿gel up¿ despite waiting for ten minutes.There was a 10-minute delay in surgery; however, there was no patient injury.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Additional information received as follows: 1.What type of procedure was performed? spine surgery.2.How was the procedure completed (adjustments, replacement, etc.)? surgeon removed the duraseal and closing.No replacement.

Event Description

N/a.

Manufacturer Narrative

The duraseal spine (204003) was not returned for analysis after three good faith attempts (gfes) were made, and the investigation could not confirm the complaint.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, per the dfmea, potential causes of failure include: issues with solution mixing and coverage.The risk remains acceptable per the risk analysis.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: DURASEAL SPINE OUS 3ML KIT 5KIT/BOX CE APPROVED
• 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: 18558232
• MDR Text Key: 333542258
• Report Number: 3003418325-2024-00001
• 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: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 204003
• Device Lot Number: 60491499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2024
• Date Device Manufactured: 09/01/2023
• 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
• Patient Age: 74 YR
• Patient Sex: Male