MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL, UNKNOWN; DURASEAL CRANIAL

Catalog Number XXX-DURASEAL

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2019

Event Type  malfunction  

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 senior neuro specialist reported on behalf of the customer that an expired duraseal (xxx-duraseal) was implanted in a patient during an unspecified surgical case on (b)(6) 2019.The product had expired one (1) month ago.There was no patient injury reported.The customer inquired about any ramifications that could possibly occur due to them implanting the expired duraseal.Additional information had been requested.

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.

Event Description

N/a.

• Brand Name: DURASEAL, UNKNOWN
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 8711566
• MDR Text Key: 148417969
• Report Number: 3003418325-2019-00019
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX-DURASEAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1