MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL EXACT SPINE SEALANT SYSTEM 3ML US BOX OF 5; DURASEAL SPINE

Catalog Number 206320

Device Problem Defective Device (2588)

Patient Problems Cerebrospinal Fluid Leakage (1772); Injury (2348)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that the 206320 duraseal exact spine sealant system failed and was defective.Additional information received on 11sep2019 and 19sep2019 indicating that the product failed, dura leak went through duraseal, underneath and over during a laminectomy and microdiscectomy procedure on (b)(6) 2019.It never occurred in the past.A 30-minute delay in surgery was noted however no adverse consequences observed due to delay.The patient had to get a dural patch repair.

Manufacturer Narrative

The device was not returned for evaluation.A device history record review was performed and at the time of manufacturing, records from each manufacturing lot were thoroughly reviewed to ensure that products were released meeting all quality release specifications.The reported complaint was not confirmed.Root cause could not be reliably determined.

• Brand Name: DURASEAL EXACT SPINE SEALANT SYSTEM 3ML US BOX OF 5
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 9142708
• MDR Text Key: 165205195
• Report Number: 3003418325-2019-00030
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 206320
• Device Lot Number: 60146709
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1