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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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 sutures 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 sutures used in this procedure? are the product code and lot numbers available for all ethicon devices used? citation: clinical neurology and neurosurgery 125 (2014) 137¿142.Http://dx.Doi.Org/10.1016/j.Clineuro.2014.07.026 - (b)(4).

Event Description

It was reported in journal article "octyl-cyanoacrylate skin adhesive is effective for wound closure in posterior spinal surgery without increased risk of wound complications¿ that the patient underwent c3/4 corpectomy with c2-5 interbody hardware, c2-6 pedicle screw and rod construct (psr) and suture was used.The procedure was performed during the period july 2010 through april 2013.For intradural case, the dura was closed with suture in the simple running fashion.Leaks were patched using an autologous muscle patch secured using interrupted suture.The patient experienced infection and was treated with antibiotics.Additional information has been requested.

• 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 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7207935
• MDR Text Key: 97847849
• Report Number: 2210968-2018-70373
• 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: Other
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR