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

Catalog Number 202050

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device will 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 sales representative reported in behalf of the customer that the 202050 duraseal dural sealant system 5ml expanded five times of its original size that caused cauda equina syndrome.The date of the event was not specified.Revision/medical intervention was required.Additional information has been requested.

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

Manufacturer Narrative

Additional information received on 13mar2019 in a medwatch form (uf/importer report #: 0500840000-2019-8003) with the following information: a female patient was placed with 202050 duraseal dural sealant system during spine surgery procedure.Upon follow up appointment, patient had imaging studies, which demonstrated that the duraseal product had expanded and caused cauda equina on feb2019.Udi #: (b)(4).

Event Description

N/a.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• MDR Report Key: 8451276
• MDR Text Key: 139813474
• Report Number: 3003418325-2019-00006
• 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,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 202050
• Device Lot Number: N8A1127X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1