MAUDE Adverse Event Report: ETHICON INC. NUROLON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product (nurolon suture) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product (nurolon suture) involved? citation: world neurosurg.2015; 83(1): 87-92.Doi: http://dx.Doi.Org/10.1016/j.Wneu.2012.11.073.(b)(4).

Event Description

It was reported via journal article: "title: local vascularized flap reconstruction of the skull base¿clinical outcomes and analysis".Authors: scharukh jalisi, brian o¿gara, gentian toshkezi, lawrence chin.Citation: citation: world neurosurg.2015; 83(1): 87-92.Doi: http://dx.Doi.Org/10.1016/j.Wneu.2012.11.073.The purpose of this study was to describe the effectiveness of local vascularized flaps for the repair various skull base defects.The authors analyzed a cohort of 18 patients (9 male and 9 female patients; age range: 2 to 74 years old) who underwent skull base surgery in a retrospective review of all head and neck surgical oncology cases done at a major tertiary care center between 2005 and 2008.The reconstructive team is responsible for incision planning and harvesting all necessary flaps.Once the resection is completed, the team starts with closure of dural defect with nurolon sutures (ethicon).Reported complications included a (b)(6) female patient with csf leak, a (b)(6) female patient with csf leak and meningitis, a (b)(6) male patient with csf leak, pneumocephalus (n-1), and failure of repair (n-1).It was concluded that local vascularized flap utilization in open reconstruction of the skull base has an excellent success rate, with no second donor site morbidity.The success is comparable to free tissue transplant reconstruction and should be in the armamentarium of every neurosurgeon and skull base surgeon.

• Brand Name: NUROLON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8021103
• MDR Text Key: 125597146
• Report Number: 2210968-2018-76840
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR