MAUDE Adverse Event Report: ETHICON INC. BONE WAX UNKNOWN PRODUCT; WAX, BONE

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Meningitis (2389); Post Operative Wound Infection (2446)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Related events reported via 2210968-2023-03469 and 2210968-2023-03471.Citation cite: j neurol surg b skull base 2022;83:185¿192.Doi https://doi.Org/10.1055/s-0040-1721815.

Event Description

Title: retrosigmoid craniectomy with a layered soft tissue dissection and hydroxyapatite reconstruction: technical note, surgical video, regional anatomy, and outcomes.The aim of this study was to report the technical nuances developed by two senior skull base surgeons for retrosigmoid craniectomy with reconstruction and provide anatomic dissections, the regional soft tissue and bony anatomy as well as the steps for our retrosigmoid craniectomy were recorded with photographs, anatomic dissections, and video.Records from 2017 to 2019 were reviewed to determine the incidence of complications after the authors began using the described approach.The inferior bony removal extends toward but not into the foramen magnum.Mastoid air cells are sealed with absorbable bone wax.For closure a dural xenograft is frequently required and is sutured in place with 4¿0 braided nylon suture (nurolon, johnson & johnson) ,the two fascial incisions are then closed with interrupted sutured technique using 2¿0 absorbable suture (vicryl, johnson & johnson).The skin flap is turned down over the repair and the subcutaneous tissue and galeal closed with a running 2¿0 absorbable stitch (vicryl, johnson & johnson) reported complications included pseudomeningoceles (n=4) , csf rhinorrhea (n=2) , wound infection(n=1), aseptic meningitis (n=1) in conclusion the relevant regional anatomy and a revised technique for retrosigmoid craniectomy with reconstruction have been presented with acceptable results.Readers can consider this technique when using the retrosigmoid approach for pathology in the cerebellopontine angle.

• Brand Name: BONE WAX UNKNOWN PRODUCT
• Type of Device: WAX, BONE
• 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: 16896143
• MDR Text Key: 314842052
• Report Number: 2210968-2023-03470
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-AMEND
• 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: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/09/2023
• 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): Required Intervention