MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-04 for PROSTHESIS UNK PROSTHESIS manufactured by Medtronic Xomed Inc..
[94517517]
Note: this is 2 of 2 mdr's being filed for this research article; it is reporting on the product problems. The first mdr reported on the alleged adverse event. 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.
Patient Sequence No: 1, Text Type: N, H10
[94517518]
This file will investigate the results documented in the following article: kong js, jeong cy, shim mj, kim wj, yeo sw, park sn. Comparative 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) malfunction / product type (polycel or titanium) / number of patients: dislocation of prosthesis? Polycel - 21 dislocation of prosthesis? Titanium - 2 porp extrusion? Polycel? 2 porp extrusion? Titanium? 0 torp extrusion? Polycel? 4 torp extrusion? Titanium? 2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2017-00443 |
| MDR Report Key | 7080881 |
| Date Received | 2017-12-04 |
| Date of Report | 2017-12-04 |
| Date Mfgr Received | 2017-11-08 |
| Date Added to Maude | 2017-12-04 |
| 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 | ANGIE DEMO |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328355 |
| 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 | 0 |
| Brand Name | PROSTHESIS |
| Product Code | ETA |
| Date Received | 2017-12-04 |
| Model Number | UNK PROSTHESIS |
| Catalog Number | UNK PROSTHESIS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-12-04 |