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

Catalog Number	W31G
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Additional 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.What was the indication for use of the bone wax during cranial vault procedure? how much bone wax was used? can you describe how much bleeding (in cc)? when did the bleeding occur (during procedure or post op)? if post op, how many days post op initial procedure? what was performed to stop the bleeding? what medical or surgical intervention was indicated? was any transfusion indicated? was the patient post op care altered due to the bleeding? what are the patient age, gender, weight, prior medical history? what is the surgeon¿s opinion as to the contributing factor to the patient event? what is the current condition of the patient?.
Event or Problem Description
It was reported that a patient underwent cranial vault expansion procedure on unknown date and bone wax was used.The bone wax did not adhere to the skull and did not stop bleeding.The patient experienced excessive bleeding.It is unknown how the procedure was completed.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: happened in surgery only one package was used dr.(b)(6) used a hemostatic product to stop the bleeding no adverse effects reported.

• Brand Name: BONE WAX
• Common Device Name: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7527384
• Report Number: 2210968-2018-72916
• Device Sequence Number: 1333531
• Product Code: MTJ
• UDI-Device Identifier: 10705031056992
• UDI-Public: 10705031056992
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: W31G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention