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); Unspecified Infection (1930)

Event Date 05/23/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 5/2/2023.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.H6 component code: g07002 ¿ device not returned the single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation cite: journal of clinical neuroscience 89 (2021) 354¿359 https://doi.Org/10.1016/j.Jocn.2021.05.048.

Event Description

Title: fluoroscopic versus ct-guided cortical bone trajectory pedicle screw fixation: comparing trajectory related complications the objective of thsi study was to compare fluoroscopic versus ict navigation for cortical bone trajectory (cbt) pedicle screw fixation.Retrospectively the surgeons reviewed all patients who underwent cbt screw fixation with either fluoroscopic or ict guidance for lumbar degenerative disease.Overall, 38 consecutive patients who underwent cbt screw fixation were included in this study.Nineteen patients had their surgery performed with fluoroscopic guidance and another 19 with ict guidance.Duraplasty was performed using 4.0 nurolon (ethicon, somerville, nj) suture, fat graft and fibrin sealant reported complications included csf leaks (n=2), postoperative infection (n=3) in conclusion to our knowledge, this is the first study to compare fluoroscopy versus ict for cbt pedicle screw fixation.We found statistically significant decreased trajectory-related complications with ictguided cbt screw fixation as compared to fluoroscopic guidance.Future studies should seek to compare outcomes across multiple centers, not only focusing on differences in accuracy and complications, but also operative time between these two navigation modalities.

• Brand Name: NUROLON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16857566
• MDR Text Key: 314442319
• Report Number: 2210968-2023-03193
• 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,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• 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: 04/26/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other