MAUDE Adverse Event Report: MEDTRONIC XOMED INC. PROSTHESIS

Model Number UNK PROSTHESIS

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

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

Note: this is 1 of 2 mdr's being filed for this research article; it is reporting on the alleged adverse events (reperforation).The second mdr will report the product malfunctions.Product evaluation: analysis results are not available; device not returned for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

This file will investigate the results documented in the following article: kong js, jeong cy, shim mj, kim wj, yeo sw, park sn.Com parative study of new autologous material, bone-cartilage composite graft, for ossiculoplasty with polycel and titanium.Clin otolaryngol.2017;00:1¿6.Https://doi.Org/10.1111/coa.12987 ¿objective: ossiculoplasty is a surgical procedure that recreates sound transmission of the middle ear in conductive hearing loss.Various materials have been used for ossicular reconstruction, but the most ideal material for ossiculoplasty remains controversial.The purpose of this study was to introduce a novel method of autologous ossiculoplasty, bone-cartilage composite graft (bccg) and to compare its surgical results with different types of ossiculoplastic prostheses.¿ polycel (n = 213) titanium (n=20) porp (n = 201) torp (n = 74) reperforation ¿ polycel - 15 (patients) reperforation ¿ titanium - 1 (patient).

• Brand Name: PROSTHESIS
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer Contact: angie demo ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328355
• MDR Report Key: 7080827
• MDR Text Key: 93685331
• Report Number: 1045254-2017-00442
• Device Sequence Number: 1
• Product Code: ETA
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK PROSTHESIS
• Device Catalogue Number: UNK PROSTHESIS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other