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

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the manufacturing record evaluation cannot be reviewed as the lot number has not been provided.No specific patient information regarding additional events has been provided.If further information is received, the file will be reviewed and updated accordingly.Citation: ann otol rhinol laryngol.2004; 113.(b)(4).

Event Description

It was reported via a journal article: title: enlarged translabyrinthine approach for the management of large and giant acoustic neuromas: a report of 175 consecutive cases author/s: mario sanna, md, alessandra russo, md, maurizio falcioni, md, abdelkader taibah, md, manoj agarwal, dlo rcs  citation: ann otol rhinol laryngol.2004; 113 the translabyrinthine approach was once considered inadequate for the removal of acoustic neuromas (ans), but that theory has few proponents today.Over the years, the translabyrinthine approach has been modified into the enlarged translabyrinthine approach, with experience and technical refinements leading to a wider access.Between april 1987 and december 2001, the gruppo otologico of piacenza-rome was able to remove 175 ans (age range: 18 to 79 years old; 95 male and 80 female patients) by adopting this modified surgical technique.During the surgical procedure, if necessary, it is possible to decompress a high jugular bulb with the help of a large diamond bur, thus keeping the surrounding periosteum intact.The bulb then needs to be detached very carefully from the bone and pushed down with the protection of a large piece of tabotamp absorbable hemostatic material (ethicon), which will also control possible bleeding.A large piece of bone wax (ethicon) is then laid on the absorbable hemostatic material, which serves to keep the bulb in its new position, as well as protect it from the bur.Reported complications included cerebellopontine angle hematoma (n-2) which required surgical drainage of the hematoma, subarachnoid hemorrhage (n-1), subdural parietal hematoma (n-1), and brain stem hematoma (n-1).From the results, the authors can conclude that the use of the enlarged translabyrinthine approach in an surgery is not dependent on tumor size.On the contrary, the advantages of a low rate of morbidity and a short hospital stay are ample proof that this is the best approach for the removal of large ans.

• Brand Name: BONE WAX UNKNOWN PRODUCT
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9197355
• MDR Text Key: 167151866
• Report Number: 2210968-2019-88719
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/20/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 10/16/2019
• 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