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

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994); 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 products (nurolon suture, vicryl suture, prolene suture, ethilon 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 products (nurolon suture, vicryl suture, prolene suture, ethilon suture) used in this procedure? citation: neurosurgery 74:77¿87, 2014; doi: 10.1227/neu.0000000000000156 - (b)(4).

Event Description

It was reported via journal article: "title: intraspinal stem cell transplantation in amyotrophic lateral sclerosis: a phase i trial, cervical microinjection, and final surgical safety outcomes".Author(s): jonathan riley, md, jonathan glass, md, eva l.Feldman, md, phd, meraida polak, bsn, rn, jane bordeau, rn, thais federici, phd, karl johe, phd, nicholas m.Boulis, md.Citation: neurosurgery 74:77¿87, 2014; doi: 10.1227/neu.0000000000000156.This open-label phase i safety trial aimed to assess the safety of a direct microinjection-based technique and the toxicity of neural stem cell transplantation to the ventral horn of the cervical and thoracolumbar spinal cord and to present cervical and cervical plus thoracolumbar microinjection group perioperative morbidity.A total of 15 patients in 5 cohorts who undergone stem-based treatment for amyotrophic lateral sclerosis were included.In group a (n=6) patients received unilateral or bilateral microinjection (3 each) and were non-ambulatory; group b (n=3) received unilateral microinjection and were ambulatory; group c (n=3) received bilateral microinjection and were ambulatory; and group d (n=3) and group e (n=3) received unilateral cervical or unilateral cervical + bilateral thoracolumbar microinjection.A total of 6 patients (group d and e; n=4 male and n=2 female) underwent unilateral cervical microinjections.In the procedure, dural closure was completed with a running 4-0 nurolon suture.Fascia was closed with 2-0 prolene, subcutaneous layer closed with inverted 2-0 vicryl and skin with running 2-0 ethilon suture.A (b)(6)-year-old male patient experienced wound dehiscence, infection (positive for a polymicrobial), incisional pain, muscle pain and neck pain.He underwent superficial wound irrigation and debridement with operative reclosure, received a peripherally inserted central catheter and an outpatient course of intravenous antibiotics.He underwent second reoperation, wound culture and hardware removal secondary to the presence of ongoing neck pain.Operative facet joint compromise and known loss of preoperative cervical lordosis may contribute to progressive deformity, it remains unclear as to whether als-associated erector spinae neuromuscular dysfunction may also be contributory.A preoperative loss of cervical lordosis and the presence of underlying progressive neuromuscular dysfunction may both serve as risk factors for the development of postoperative kyphosis.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• 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: 8001801
• MDR Text Key: 124962812
• Report Number: 2210968-2018-76753
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• 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: 10/09/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR