MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED

Catalog Number 203001

Device Problem Leak/Splash (1354)

Patient Problems Cerebrospinal Fluid Leakage (1772); Hemorrhage, Cerebral (1889); Complaint, Ill-Defined (2331)

Event Date 09/18/2015

Event Type  Injury  

Event Description

This is the first of two reports.It was reported that duraseal xact used on (b)(6) 2015 and there was a leak on (b)(6) 2015.Additional information was received on 23 sep 2015 with the following: the patient had a removal of a neurofibroma and had duragen plus and duraseal xact used for dural repair.A suction drain was sited.Very soon post-operatively, the patient had a cerebral bleed and had a cerebrospinal fluid (csf) leakage evident by the volume in the drain.The patient became very "unwell" and was transferred to the nearest hospital.The event did not lead to an increase of surgery time.No product will be returned because it is still implanted.Additional information was received on 08 oct 2015 with the following: the patient did have two further operations after the neurofibromas removal but neither of the operations the physician believed were due to the csf leak but the cerebral bleed the patient sustained post operatively.The patient is improving.The physician explained his technique of using duragen and duraseal: he applied the duragen plus correctly but it appeared he didn't have the end tip on the y connector of the duraseal for whatever reason as he did not get a spray effect.He also said that he covered only the perimeter (outer edge) of the duragen plus with duraseal xact.A drain was placed and then closed.It wasn't a suction drain but a gravity.

Manufacturer Narrative

Integra has completed their internal investigation on 12/09/2015.The investigation included: methods: review of device history records, review of complaints history.Results: a review of the device history records has been performed.This review confirmed that this lot of products was reviewed and released according to qa specifications.A review of historical complaint data displayed no increase in trends.Conclusion: the clinically applied product was not returned to us for evaluation; therefore, we are unable to identify the specific cause for the problem reported.Records from each manufacturing lot are thoroughly reviewed to ensure that our products are released meeting all current specifications.Although a specific root cause analysis could not be performed, the incident is maintained in our database for a broader trend analysis.If additional information is obtained, or the sample is returned, we will re-open this investigation.

• Brand Name: DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5151339
• MDR Text Key: 28311267
• Report Number: 3003418325-2015-00019
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dental Hygienist
• Type of Report: Followup
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 203001
• Device Lot Number: N4F1065X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other