MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION INTEGRA DURASEAL DURAL SEALANT SYSTEM; SEALANT, DURAL

Model Number 202050

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

Event Date 10/16/2023

Event Type  Injury  

Event Description

During a spinal procedure the surgeon asked for a duraseal which is used when there is a tear in the dura.The scrub assembled the syringes for the duraseal and 2 out of the 3 spray caps included in the package would not work.An additional package was utilized in order for the surgeon to complete the procedure.Reference report #mw5148276.

• Brand Name: INTEGRA DURASEAL DURAL SEALANT SYSTEM
• Type of Device: SEALANT, DURAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 18170296
• MDR Text Key: 328689266
• Report Number: MW5148275
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2024
• Device Model Number: 202050
• Device Lot Number: 60392121
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White