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U.S. Department of Health and Human Services

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

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ETHICON INC. BONE WAX UNKNOWN PRODUCT; WAX, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cerebrospinal Fluid Leakage (1772); Meningitis (2389); Post Operative Wound Infection (2446)
Event Date 02/22/2021
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 reported via 2210968-2023-03469 and 2210968-2023-03471.Citation cite: j neurol surg b skull base 2022;83:185¿192.Doi https://doi.Org/10.1055/s-0040-1721815.
 
Event Description
Title: retrosigmoid craniectomy with a layered soft tissue dissection and hydroxyapatite reconstruction: technical note, surgical video, regional anatomy, and outcomes.The aim of this study was to report the technical nuances developed by two senior skull base surgeons for retrosigmoid craniectomy with reconstruction and provide anatomic dissections, the regional soft tissue and bony anatomy as well as the steps for our retrosigmoid craniectomy were recorded with photographs, anatomic dissections, and video.Records from 2017 to 2019 were reviewed to determine the incidence of complications after the authors began using the described approach.The inferior bony removal extends toward but not into the foramen magnum.Mastoid air cells are sealed with absorbable bone wax.For closure a dural xenograft is frequently required and is sutured in place with 4¿0 braided nylon suture (nurolon, johnson & johnson) ,the two fascial incisions are then closed with interrupted sutured technique using 2¿0 absorbable suture (vicryl, johnson & johnson).The skin flap is turned down over the repair and the subcutaneous tissue and galeal closed with a running 2¿0 absorbable stitch (vicryl, johnson & johnson) reported complications included pseudomeningoceles (n=4) , csf rhinorrhea (n=2) , wound infection(n=1), aseptic meningitis (n=1) in conclusion the relevant regional anatomy and a revised technique for retrosigmoid craniectomy with reconstruction have been presented with acceptable results.Readers can consider this technique when using the retrosigmoid approach for pathology in the cerebellopontine angle.
 
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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 Key16896143
MDR Text Key314842052
Report Number2210968-2023-03470
Device Sequence Number1
Product Code MTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PRE-AMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/09/2023
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/26/2023
Initial Date FDA Received05/09/2023
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 Number1
Patient Outcome(s) Required Intervention;
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