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

Device Problems Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)

Patient Problems Headache (1880); Thrombosis (2100); Tinnitus (2103); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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.Was the case ((b)(6) male) discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product (bone wax) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure?.

Event Description

It was reported in a journal article entitled: bone wax extrusion through postauricular wounds: a case series author(s): samantha m.Baird, mbbs (hons); bing m.Teh, mbbs, phd; kelvin k.M.Lim, mbbs, franzcr; matthew c.Campbell, mbbs, fracs citation: laryngoscope, 128:369¿372, 2018 / doi: 10.1002/lary.26697.The purpose of this case series is to discuss complications associated with intraoperative bone wax use and discuss alternative hemostatic agents.A (b)(6) male patient underwent a second revision mastoidectomy for recurrent mastoid cavity infection.Intraoperatively, the sigmoid sinus was inadvertently breached, requiring bone wax (ethicon) for hemostasis.Postoperatively, the patient developed intractable headaches with bilateral papilloedema secondary to increased intracranial pressure in the setting of ipsilateral transverse and sigmoid sinus thromboses, diagnosedon computed tomography.The headaches were mainly situated in the left postauricular and mastoid region and radiated to the left temporal area with associated hyperacusis, pulsatile tinnitus, and intermittent lightheadedness.The patient¿s headaches did not respond to analgesia and 6 months of anticoagulation with warfarin.Eight months postoperatively, the patient reported recurrent episodes of extrusion of foreign body from the initial postauricular wound.Exploration of mastoid cavity was done.Histopathology confirmed fibroconnective tissue with a foreign body reaction.Over the next month, the patient¿s headaches continued.Due to failed conservative measures and initial immediate symptomatic relief of symptoms with removal of bone wax, we decided to explore his mastoid cavity once again.Again, more bone wax was removed from the sigmoid sinus further distally.Immediately postoperatively, the patient¿s headache completely resolved and he returned to his premorbid function.In this case, no response to anticoagulation and analgesia, yet immediate symptomatic relief of the patient¿s headache following surgical bone wax removal suggests that sinus venous thrombus occurred secondary to the presence of bone wax.The patient was treated with 5 months of warfarin, with no clinical improvement, suggesting that thrombosis from foreign material could not be lysed but instead required removal.Bone wax is a relatively safe hemostatic agent.However, significant complications can occur due to its nonresorbable property, as reported here.Bone wax should be used judiciously, particularly in infected fields and in patients with general immuno hypersensitivity; for these, alternative hemostatic agents should be considered.

• Brand Name: BONE WAX
• 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. BRAZIL; rodovia presidente dutra; sao paolo ; BR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8475563
• MDR Text Key: 140690749
• Report Number: 2210968-2019-79914
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR