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..
[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
| Report Number | 1045254-2016-00406 |
| MDR Report Key | 6129543 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-28 |
| Date of Report | 2016-11-01 |
| Date Mfgr Received | 2017-02-10 |
| Date Added to Maude | 2016-11-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSTHESIS - POLYCEL |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2016-11-28 |
| Model Number | 1156363 |
| Catalog Number | 1156363 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-11-28 |