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 Hearing Impairment (1881); Paralysis (1997)

Event Date 10/08/2021

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 captured via 2210968-2023-03184, 2210968-2023-03185, 2210968-2023-03186, 2210968-2023-03187, 2210968-2023-03188, 2210968-2023-03189 and 2210968-2023-03191 citation cite: j neurosurg 136:1097¿1102, 2022.Https://thejns.Org/doi/abs/10.3171/2021.5.Jns204130.

Event Description

Title: retrolabyrinthine transsigmoid approach to complex parabrainstem tumors in the posterior fossa.The objectives of this study was to describe the transsigmoid approach, investigate its feasibility for the treatment of posterior fossa tumors in a clinical study, and compare it to other surgical approaches in a cadaveric study.For the clinical study, the authors retrospectively reviewed the medical records and operative charts of patients who had been surgically treated for parabrainstem tumors using the transsigmoid approach between 1997 and 2019.They analyzed patient demographic and clinical data, as well as surgical and clinical outcomes.A total of 21 patients (6 males and 15 females) with a mean age of 42.2 (range 15¿67) years were included in the clinical study.3-0 nurolon suture was used to double ligate the sigmoid sinus and for closure bone wax is applied to the mastoid air cells.Reported complications included 52 years old female postop facial palsy.45 years old male postop hearing loss.62 years old female postop hearing loss and facial palsy.20 years old male postop facial hypesthesia, hearing loss, diplopia.In conclusion the transsigmoid approach is useful for complex parabrainstem tumors in the posterior fossa because it provides a wider and shallower operative view.This enables less cerebellar retraction and reduces the risk of damage to important structures in the posterior fossa, resulting in better operative and clinical outcomes.

• 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: 16853825
• MDR Text Key: 314386590
• Report Number: 2210968-2023-03190
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial

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
• Patient Age: 62 YR
• Patient Sex: Female