MAUDE Adverse Event Report: ETHICON INC. BONE WAX; STERILE NONABSORBABLE BONE WAX

Catalog Number W810T

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

Patient Problems Inflammation (1932); Pain (1994); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 10/25/2021

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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure? date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? were any pre-op cleansing procedures or products changed recently? if yes, please describe.Where in the patient¿s body was the bone wax placed? was the excess bone wax removed from the operative site? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? were cultures performed? results? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? if applicable, will product be returned? if so, please provide the return date and tracking information.

Event Description

It was reported that a patient underwent a surgical procedure for trauma, diagnosed lumbar fracture on an unknown date and bone wax was used.Post-op, one week after surgery , the patient had redness, swelling and pain in the affected area.The position of the spinal fixator was normal through imaging examination.The doctor suspected that there was a problem with the use of bone wax.Local drainage was performed.According to the doctor's advice, 0.9% sodium chloride injection and 2.0g ceftriaxone sodium were given once a day.After five days, the symptoms disappeared.Additional information was requested.

Manufacturer Narrative

Product complaint # (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.Additional information was requested and the following was obtained: all answers above are unobtainable.Once there is any update, we will update the information.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: BONE WAX
• Type of Device: STERILE NONABSORBABLE BONE WAX
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paolo 12240 ; BR 12240
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12899447
• MDR Text Key: 286329297
• Report Number: 2210968-2021-12193
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: W810T
• Device Lot Number: AP0013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male