MAUDE Adverse Event Report: ETHICON INC. BONE WAX 2.5GR::; WAX, BONE

Catalog Number XCW810T

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

Patient Problems Erythema (1840); Inflammation (1932); Not Applicable (3189)

Event Date 08/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device product code w810t lot kl5dgjm, and no non-conformance were identified.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.The following information was requested, but unavailable: the patient demographic info: 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? other relevant history / concomitant medications, please clarify ¿the use of bone wax was suspected to be problematic¿? where was the device used? does the physician believe there was there any alleged deficiency with the ethicon device? what is the physician¿s opinion as to the etiology of or contributing factors to this event? if applicable, will the product be returned for evaluation? what is the patient¿s current status?.

Event Description

It was reported that the patient underwent lumbar vertebral fracture surgery on an unknown date and bone wax was used.A week following the procedure, the patient experienced erythema and inflammation.The position of the fixator was normal by imaging examination, and the use of bone wax was suspected to be problematic.The patient was given drainage and rehabilitation treatment.Then the patient's condition changed to better.

• Brand Name: BONE WAX 2.5GR::
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-UK; simpson parkway; kirkton campus; livingston
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 9125381
• MDR Text Key: 160263787
• Report Number: 2210968-2019-88151
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2019

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
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: XCW810T
• Device Lot Number: KL5DGJM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention