MAUDE Adverse Event Report: INTEGRA LIFESCIENCES HOLDING CORP DURASEAL XACT, UNKNOWN; DURASEAL SPINE

Catalog Number XXX-DURASEAL XACT

Device Problems Fluid/Blood Leak (1250); Device Inoperable (1663)

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); No Information (3190)

Event Type  Injury  

Event Description

The patient stated that she had a spinal surgery two years ago in which duraseal was used.She stated it didn't work and she had to have another surgery.No other information was provided.Attempts made to obtain additional information.

Manufacturer Narrative

It is unknown if the device involved in the reported incident is expected to be returned for eval.An investigation has been initiated based upon the reported information.

Manufacturer Narrative

Additional information obtained on 17aug2015 from the customer: patient was part of a (b)(6) study (site and patient number not provided).Patient had a laminectomy and decompression with resection of intradural tumor on (b)(6) 2013 for a stenosis l4-l5 compression sacral sac, intradural mass t2 level at (b)(6).4-0 nurolon was used on the dura and a layer of duragen was placed, followed by duraseal exact.The patient reported that the duraseal did not work; it did not seal and another surgery was warranted.After 4-5 days after the (b)(6) 2013 surgery, the wound was still draining spinal fluid and blood, so the surgeon put stitches on the wound.The patient was discharged on (b)(6) 2013.Then on (b)(6) 2013, the patient had to undergo surgery to removed the duraseal.The patient stayed in the hospital for 7 days.On (b)(6) 2014, the patient was admitted for infection.The id physician (infectious disease) treated the infection like (b)(6).Plcc line was inserted and the patient was treated for the infection for 7 days.The patient stated she has had difficulty walking.No other information was provided.Integra has completed their internal investigation on 06aug2015: as no lot number was provided, a review of the device history record could not be performed.All process and test criteria are verified as complying with the finished product specifications for all released lots.A review of historical complaint data displayed no increase in trends.The product sample was not returned for analysis.Without the sample and without a valid lot/serial number, a detailed investigation could not be performed.

Manufacturer Narrative

Additional information received on 02sep2015 with the following: the lot number of the duraseal xact that was implanted on the patient was n3h1916x.Follow up visit of the patient on (b)(6) 2014 showed no csf leak or infection.However, it was noted "abnormal wound healing".No sae was noted in the clinical database.Additional information in the form of operative note was received on 03sep2015 with the following relevant information: operative notes from (b)(6) 2013 (operative procedure: l2-l4 laminectomy and decompression with resection of intradural tumor with the use of neuromonitoring) neuromonitoring had been placed prior to start of the procedure and was used to stimulate the nerve roots.There was motor function form the involved root.The screw was then carefully dissected from around the tumor and the tumor was removed en bloc and passed off the field and sent for both permanent and frozen, initial frozen was consistent with a schwannoma.Monitoring remained stable throughout and there was good stimulation of that nerve root, both before and after removal of the tumor.Once that was done, pristine hemostasis was obtained.Attention was turned to closing the dura.The dura was reapproximated with 4-0 nurolons in a simple running fashion.Once this was done, a layer of duragen was placed followed by duraseal exact.Next, the incision was irrigated with copious amount of bacitracin irrigation solution and hemostasis was obtained with bipolar electrocaustery and floseal.Once this was done, 1 g of vancomycin powder was placed into the wound and the fascia was reapproximated with 0 vicryls.A 10 french jp drain was then placed, tunneled out through the skin and secured with a drain stitch.The dermis was reapproximated with 2-0 vicryls followed by a 4-0 monocryl in simple running fashion of the skin.The incision was dressed with bacitracin, xeroform, telfa, 4x4s and tegaderm.The patient tolerated the procedure well without any complications.Operative notes from (b)(6) 2013 (operative procedure:revision of lumbar wound with irrigation and debridement) -date of operation: (b)(6) 2013.-preoperative diagnosis: wound dehiscence -postoperative diagnosis: same -estimated blood loss: less than 100ml -findings: the patient recently underwent a lumbar laminectomy and resection of the intradural tumor on the 17th of last month.The patient has had continued drainage from the wound site over the past several weeks despite placement of additional stitches, this was concerning for csf leak.The old incision was opened bluntly with metzenbaum and the dissection was carried down through the fascia.There as was a large cavernous area beneath the fascia with a large fluid collection, which appeared consistent with old hematoma.There did not appear to be any purulent material.There was some loose granulation tissue, which was sent for microbiology, but again no overt signs of infection.The resection was carried all the way down to the thecal sac, where the previous duragen and the duraseal was encountered and removed.There appreared to be no leakage of csf from the previous dural opening site, the suture line was intact.The surgeon valsalva'd the patient to 40, did not reveal any csf leak.As there was no apparent area of csf leak, no repair was necessary.All sides of the incision were aggressively debrided with the use of a curette and the incision was irrigated with a liter of ortho irrigation, a liter of bacitracin irrigation.Once this was done, hemostais was obtained with bipolar electrocautery and a large 19 french jp drain was placed, tunneled out through the skin and secured with a drain stitch.A 2 g of vancomycin powder were placed in to the wound the fascia was reapproximated with 0 vicyrls, flowed by 2-0 vicryl and a deep dermal stitch, followed by 3-0 nylon in a simple running fashion to the skin.The incision was dressed with bacitracin, xeroform, telfa, 4x4s and tegaderm.The patient tolerated the procedure well without any complications.After the case, the patient was extubated and taken to pacu in stable condition.

Manufacturer Narrative

The product id that corresponds with the lot number provided (n3h1916x) is 206520.Integra has completed their internal investigation on 12/04/2015.The investigation included: methods: review of device history records.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.The clinically applied product was not returned to integra 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.

• Brand Name: DURASEAL XACT, UNKNOWN
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA LIFESCIENCES HOLDING CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4846694
• MDR Text Key: 5812391
• Report Number: 3003418325-2015-00012
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,company representative,con
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX-DURASEAL XACT
• Device Lot Number: N3H1916X.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 55 YR