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

Catalog Number 206520

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A customer reported that the 206520 duraseal exact spine sealant was used during a fusion spine cervical anterior posterior on (b)(6) 2020.The sealant was opened to sterile field, and was prepared, per manufacturers, by the scrub nurse.The surgeon stated that the sealant did not work properly.The sealant was in contact with the patient with no patient injury.There was no delay in the procedure.Additional information has been requested.

Manufacturer Narrative

Unique device identifier (udi): unknown part number, attempts to obtain product were unsuccessful, udi unavailable.Duraseal was not returned for evaluation (discarded by customer); therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 1000 campus drive; 1000 campus drive; princeton NJ 08536
• MDR Report Key: 10744838
• MDR Text Key: 213901552
• Report Number: 3003418325-2020-00019
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 206520
• Device Lot Number: 60224793
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1