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

Catalog Number 206520

Device Problems Failure To Adhere Or Bond (1031); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Vomiting (2144); Injury (2348)

Event Date 01/09/2016

Event Type  Injury  

Event Description

Cov-drss-0002 duraseal exact spine sealant post-approval study: subject number: (b)(6).(b)(4).(b)(6) white male with an extensive medical history which includes low back pain, left leg pain, idiopathic scoliosis and ddd (degenerative disc disease).His surgical history includes l5/s1 microhemilaminotomy/discectomy.On (b)(6) 2016, the subject underwent surgery for a recurrent disc herniation.Procedures performed included discectomy, decompression and anterior interbody instrumentation with fusion.The procedure resulted in an incidental durotomy.The durotomy was closed using duraseal exact sealant.At the time of this report, no other materials were described as being used to close the dura tear or the main wound.On (b)(6) 2016, the subject experienced a csf leak.During index hospitalization, the subject was taken back to surgery on (b)(6) 2016 and a subarachnoid drain was placed.Surgeon noted that the patient displaced/disrupted placement of duraseal product while vomiting post-operatively, causing the csf leak to occur.The subject was discharged on (b)(6) 2016 and is pending the 90 day post-operative visit.The event was noted as a serious adverse event.It required inpatient hospitalization and/or a prolongation of existing hospitalization.The pattern is continuous, of moderate severity, surgical intervention was required, the patient's outcome is continuing and therefore the event is still ongoing.The relationship of the event to the device was classified as probably related.

Manufacturer Narrative

Integra completed its internal investigation on 14 mar 2016.The product was not returned for evaluation.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 for evaluation; therefore, the specific cause for the problem reported could not be identified.If additional information is obtained, or the sample is returned, this investigation will be re-opened.

• Brand Name: DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer Contact: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5456456
• MDR Text Key: 38879264
• Report Number: 3003418325-2016-00003
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 206520
• Device Lot Number: N5H0937X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2015
• 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): Hospitalization
• Patient Age: 25 YR