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

Model Number	202050
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Product placed during spine surgery procedure.Upon follow up appointment patient had imaging studies which demonstrated duraseal product had expanded and caused cauda equina.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM
• Common Device Name: SEALANT, DURAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 8403132
• Report Number: 8403132
• Device Sequence Number: 389666
• Product Code: NQR
• UDI-Device Identifier: 10381780000020
• UDI-Public: (01)10381780000020
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/06/2019
• Report Date (Section F): 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 202050
• Device Catalogue Number: 202050
• Device Lot Number: N8A1127X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/06/2019