MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5; DURASEAL CRANIAL

Catalog Number 202050

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

The device is unlikely to be returned to the manufacturer for analysis as it still is currently implanted in the patient.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

An integra account executive reported that the customer opened the 202050 duraseal dural sealant system 5ml and implanted an expired duraseal on (b)(6) 2019.There was no patient injury/death alleged.Additional information was received on 13jun2019 indicating that the product was used for a left frontal craniotomy, orbitozygomatic osteotomy, posterior orbitotomy, anterior clinoidectomy, partial resection of sphenocavernous/orbital meningioma.There was no revision/medical intervention done.The surgeon was notified and there was no further treatment indicated.

Event Description

N/a.

Manufacturer Narrative

There was no product received back, as such only a dhr review was conducted.The dhr review concluded there were no assembly component related failures at the time of release.With the information provided a root cause could not be reliably determined.Further, the use of product beyond its expiration date is not how the product is intended to be used as it compromises the efficacy of the product.The reported complaint was not confirmed.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 8758921
• MDR Text Key: 150007591
• Report Number: 3003418325-2019-00022
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• PMA/PMN Number: P040034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 202050
• Device Lot Number: N7J0683X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 07/11/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1