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

Model Number 202050

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Nerve Damage (1979)

Event Date 02/22/2019

Event Type  Injury  

Event 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
• Type of Device: SEALANT, DURAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 8403132
• MDR Text Key: 138213742
• Report Number: 8403132
• Device Sequence Number: 1
• Product Code: NQR
• UDI-Device Identifier: 10381780000020
• UDI-Public: (01)10381780000020
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 202050
• Device Catalogue Number: 202050
• Device Lot Number: N8A1127X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1