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 Problems Pain (1994); Ambulation Difficulties (2544)

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 female patient reported that her doctor used ¿a lot¿ of duraseal product during spinal surgery on (b)(6) 2019.The doctor did not specify an amount used.The exact product id of the duraseal was not known; not sure if the 3ml (206320) or 5ml (206520).The patient stated she was in extreme pain and had trouble walking or standing.The date of the event was not specified.The patient was seeking to know how long it takes for the product to absorb into her body as the pain was unbearable.Additional information has been requested but no other clinical information has been provided.

Manufacturer Narrative

The device was not returned for evaluation.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.The reported complaint was not confirmed.With the information provided a root cause could not be reliably determined.

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: 8482352
• MDR Text Key: 140906374
• Report Number: 3003418325-2019-00008
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

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: 03/12/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 04/05/2019
• Supplement Dates FDA Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1