PROSTHESIS - POLYCEL 1156363

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-11-28 for PROSTHESIS - POLYCEL 1156363 manufactured by Medtronic Xomed Inc..

Event Text Entries

[60943758] Product evaluation: analysis results not available; device not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10


[60943759] Note: this will report event 3 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), mar 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.?
Patient Sequence No: 1, Text Type: D, B5


[67450670] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[101834703] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1045254-2016-00406
MDR Report Key6129543
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-11-28
Date of Report2016-11-01
Date Mfgr Received2017-02-10
Date Added to Maude2016-11-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMICHELLE ALFORD
Manufacturer Street6743 SOUTHPOINT DRIVE NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal32216
Manufacturer Phone9043328197
Manufacturer G1MEDTRONIC XOMED INC.
Manufacturer Street6743 SOUTHPOINT DR NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal Code32216
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROSTHESIS - POLYCEL
Generic NameREPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
Product CodeETA
Date Received2016-11-28
Model Number1156363
Catalog Number1156363
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC XOMED INC.
Manufacturer Address6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 32216 US 32216


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2016-11-28

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