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

Catalog Number XXX-DURASEAL XACT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device involved will be returned to the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

An integra manager reported on behalf of the customer that duraseal (xxx-duraseal xact) caused a negative change in somatosensory evoked potential (ssep) on an unspecified date.Additional information has been requested.

Manufacturer Narrative

The device was not returned for evaluation.Dhr review could not be performed as lot number was not provided.At the time of manufacturing, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications.With the information provided a root cause could not be determined, as there is no way to reliably determine why the reported condition occurred.

Event Description

N/a.

• Brand Name: DURASEAL XACT, UNKNOWN
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 8638675
• MDR Text Key: 146043074
• Report Number: 3003418325-2019-00018
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-DURASEAL XACT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 06/25/2019
• Supplement Dates FDA Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1