MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2012-12-10 for PROSTHESIS 1112065 H/A PARTIAL 90DEG REC manufactured by Xomed Mfg Jacksonville.
[20635057]
A literature review was performed on an article published in the journal "otology <(>&<)> neurotology" in 2010 entitled, "titanium versus nontitanium ossicular prostheses - a randomized controlled study of the medium-term outcome," by matthew yung and philip smith. The article discussed a study comparing the medium-term outcome of ossiculoplasty using titanium (ti) and non-ti prostheses. The study was conducted between 2002 and 2007 on patients who required ossicular reconstructions and had cases of chronic otitis media. The patient demographics included both males and females ranging from 10 to 78 years in age, 8 of which were 16 years of age or younger. Of 94 ossiculoplasties recruited, 45 were ha prosthesis and from this 19 were ha torp and 26 were ha porp. Medtronic products were used in only the non-ti cases where the following issues reported: 1. ) prosthesis extrusion or exposure of head plate versus non-extrusion (2 cases) 2. ) cartilage plates placed over the head plate of the ha prostheses in cases of atelectasis. (cases not specified) points reported in the article: 1. ) no significant difference between ti (non-medtronic product) and non-ti (medtronic product)for both porps and torps. 2. ) no significant difference in the extrusion rate between both prostheses. 3. ) result of study is consistent with those of a previous long-term study on ossiculoplasty outcomes showing influence by middle ear pathologies rather than surgical techniques.
Patient Sequence No: 1, Text Type: D, B5
[21029865]
This device is used for therapeutic purposes. (b)(4). This is being reported from a literature review. No devices will be returning. The device was not returned and therefore no evaluation could be performed. Method: actual device not evaluated. Results: no results available since no evaluation performed. Conclusion: device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2012-00699 |
| MDR Report Key | 2863078 |
| Report Source | 03 |
| Date Received | 2012-12-10 |
| Date of Report | 2012-11-06 |
| Date Mfgr Received | 2012-11-06 |
| Date Added to Maude | 2012-12-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JACKLYN HAYMAN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042812769 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE 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 1112065 H/A PARTIAL 90DEG REC |
| Generic Name | PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT |
| Product Code | ETA |
| Date Received | 2012-12-10 |
| Model Number | 1112065 |
| Catalog Number | 1112065 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOMED MFG JACKSONVILLE |
| Manufacturer Address | 6743 SOUTHPOINT DR JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-12-10 |