MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL EXACT SPINE SEALANT SYSTEM 3ML US BOX OF 5; DURASEAL SPINE

Catalog Number 206320

Device Problems Failure To Adhere Or Bond (1031); Fluid/Blood Leak (1250); Insufficient Information (3190)

Patient Problems Cerebrospinal Fluid Leakage (1772); No Code Available (3191)

Event Date 01/11/2016

Event Type  Injury  

Event Description

(b)(4) duraseal (tm) exact spine sealant post-approval study: site #: 01, subject number: (b)(4), study arm: duraseal.Subject (b)(4) is a (b)(6) year old white male with minimal ongoing medical condition of l5-s1 herniated disc and no past relevant spinal surgical history.On (b)(6) 2015, subject's baseline neurological examination was normal for motor exam, sensory exam, deep tendon reflexes, mental status, cranial nerves; and abnormal for gait (limps on left leg).On (b)(6) 2015, subject underwent surgery for a l5-s1 disc herniation.Procedures performed included discectomy and decompression.Primary closure consisted of duraform duraplasty.Surgeon then used duraseal exact.Leak assessment after first treatment indicated that there was no leak.The main wound was then closed using sutures and floseal.Subject was discharged on (b)(6) 2015.On (b)(6) 2016, subject had a follow up mri (reason not provided).The mri was of the l-spine region and it was confirmed that the subject had a pseudomeningocele.The event was noted as an adverse event of mild severity.No treatment was performed.Principal investigator classified event as having a possible relationship to the device.The subject is pending their 90 day follow up visit where they will be examined for resolution.The event is considered ongoing.(b)(4).

Manufacturer Narrative

Integra has completed their internal investigation on 07 july 2016.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.The clinically applied product was not returned for evaluation; therefore, the specific cause for the problem reported could not be identified.Records from each manufacturing lot are thoroughly reviewed to ensure that the products are released meeting all current specifications.Although a specific root cause analysis could not be performed, the incident is maintained in the database for a broader trend analysis.If additional information is obtained, or the sample is returned, the investigation will be reopened.

• Brand Name: DURASEAL EXACT SPINE SEALANT SYSTEM 3ML 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5548588
• MDR Text Key: 41943713
• Report Number: 3003418325-2016-00007
• 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: health professional,study
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 206320
• Device Lot Number: N5E0381X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2015
• 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): Other
• Patient Age: 61 YR