MAUDE Adverse Event Report: MEDTRONIC XOMED INC. PROSTHESIS - POLYCEL; REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Model Number 1156363

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

Patient Problem Hearing Loss (1882)

Event Type  Injury  

Manufacturer Narrative

Product evaluation: analysis results not available; device not returned for evaluation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

** note: this will report event 1 of 3 in which a recipient of a polycel torp sustained sensory neural hearing loss.This file investigates the findings in ¿comparison of titanium vs.Polycel total ossicular replacement prosthesis¿, faramarzi m., et al; iranian journal of otorhinolaryngology, vol.28(2), serial no.(b)(4), (b)(6) 2016.The study was a ¿prospective randomized clinical trial study which compares the hearing result of total ossicular replacement prosthesis made of titanium with omega connector and polycel.¿ the outcomes reported were post-surgical observations collected during the research process.¿patients were classified in two groups: titanium kurz (ttp -vario system, kurz, (b)(4)) with omega connector and polycel (sheehy plastipore polycel, medtronic xomed inc).The duration of the follow up was 6-12 months.¿ polycel ¿is made with thermal-fused polyethylene material that causes little immune response and it is inserted easily in the middle ear.70-80% of this prosthesis volume is made by multiple pores of about 250 micrometer in diameter.¿ patient outcomes: ¿sensory neural hearing loss occurred in 3 patients in the polycel group (5%).¿sensorineural hearing loss is a rare complication after ossiculoplasty that may be due to trauma to the footplate causing perilymphatic leakage or due to labyrinthitis.¿.

Manufacturer Narrative

Date of this report: 11/01/2016.(b)(4).Date manufacturer received: 02/10/2017.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROSTHESIS - POLYCEL
• Type of Device: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• 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: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 6128989
• MDR Text Key: 60933246
• Report Number: 1045254-2016-00403
• Device Sequence Number: 1
• Product Code: ETA
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: K823912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1156363
• Device Catalogue Number: 1156363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability