MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,03 report with the FDA on 2012-12-10 for PROSTHESIS 1150001 UNIVERSAL TITANIUM CA manufactured by Medtronic, Inc..
[2984628]
A literature review from the article published in the journal "arch otolaryngol head neck surg" 2011 entitled "total ossiculoplasty in children: predictive factors and long-term follow-up," by jerome nevoux, md; antoine moya-plana, md; pierre chauvin, md, phd; francoise denoyelle, md, phd; erea-noel garabedian, md. Author affiliations: university pierre et marie curie, university paris 6 (drs nevoux, moya-plana, denoyelle, and garabedian), institut national de la sante et de la recherche medicale u587, pasteur institute (drs denoyelle, and garabedian), department of otolaryngology-head and neck surgery, armand-trousseau children's hospital (drs nevoux, moya-plana, denoyelle, and garabedian), and department of public health, saint antoine hospital (dr chauvin), assistance publique-ho pitaux de paris, and institut national de la sante et de la recherche medicale, unite? Mixte de recherche en sante? 707 (dr chauvin), paris, france. The following events were reported: over a period of 15 years, 116 ears were operated on, including 25 ears that were surgically treated on more than 2 occasions. Seventeen ears underwent a second operation for an auditory failing and for replacement of the prosthesis. Only 4 children were operated on bilaterally. ".... "the auditory results were unsatisfactory in 27 ears at 1 year after surgery. Three were operated on later because of a voluminous residual cholesteatoma that would not permit ossiculoplasty at the same time. Patient 6 presented with a new displacement of the prosthesis 2 years after the first one, confirmed by ct findings, but he did not undergo revision surgery.
Patient Sequence No: 1, Text Type: D, B5
[10334017]
This device is used for therapeutic purposes. (b)(4). Medical intervention. This complaint is being filed as a result of a literature review. No product will be returned for evaluation. The device was not returned and therefore, no evaluation could be performed. The following codes were not available in medtronic's gch system: 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 | 1045254-2012-00700 |
| MDR Report Key | 2863211 |
| Report Source | 00,03 |
| 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 | JONATHAN SCHLECH |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| 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 1150001 UNIVERSAL TITANIUM CA |
| Generic Name | PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT |
| Product Code | ETB |
| Date Received | 2012-12-10 |
| Model Number | 1150001 |
| Catalog Number | 1150001 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-12-10 |