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

Catalog Number 206320

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 04/10/2018

Event Type  Injury  

Manufacturer Narrative

The device will not be returned to the manufacturer for analysis; it was inadvertently thrown away by the customer.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A nurse reported that on (b)(6) 2018, a 206320 duraseal exact spine sealant system was used during a transforaminal lumbar interbody fusion (tlif) procedure.One of the surgeons attempted to use the duraseal to seal a dura tear but the product unfortunately did not work upon application.The tear continued to leak.Another duraseal was used to seal the tear.Additional information was received on 16apr2018 indicating that the product was used on a (b)(6) female patient.The product was mixed as per direction.There was no injury reported however there was a 15 minute surgery delay due to product problem and as a result, the patient was under anesthesia for a longer period.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation since the device was thrown away by the customer.Therefore the failure mode cannot be confirmed.A review of device history record indicates the product was released meeting all specifications at the time of manufacture.A definitive root cause could not be determined with regard to the reported condition.

• 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: 7471937
• MDR Text Key: 106849079
• Report Number: 3003418325-2018-00025
• 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: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• 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: N7J0003X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR