MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2017-05-01 for PROSTHESIS XOM UNK PROSTHESIS manufactured by Medtronic Xomed Inc..
[74110507]
Product evaluation: analysis results not available; device not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[74110508]
A review of the journal article? Vascularization of the long process of the malleus: surgical implications? , vallejo-valdezate, et al; eur arch otorhinolaryngol (2016) 273:2335? 2342. "the detachment of the tympanic membrane to fasten a mvp prosthesis causes a damage in the periosteal/perichondral vascular supply of the handle as well as micro-trauma on it, which can promote bone resorption at the point of anchorage by osteoclast stimulation. Respect periostea vascularization of the manubrium may be important to preventdamage in this ossicle caused by some middle ear reconstruction prostheses.? ? Data from patients who underwent a malleovestibulopexy during a 3-year period were collected. In those cases, attention was focused on the permanence of the prostheses and their position, the presence of erosion in the long process of the malleus and the endotympanic pressure.? Results report that? In 3 of the cases, the prosthesis extruded spontaneously leaving some kind of damage [erosion or complete fracture] of the long process of the malleus.? This file will investigate a patient who underwent "a revision tympanoplasty. " follow up with the patient occurred 16 months post operatively. It was found that there was an "absence of prosthesis and a fracture in the middle third of the handle. "
Patient Sequence No: 1, Text Type: D, B5
[101836323]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2017-00136 |
| MDR Report Key | 6534902 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2017-05-01 |
| Date of Report | 2017-04-06 |
| Date Mfgr Received | 2017-04-06 |
| Date Added to Maude | 2017-05-01 |
| 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 |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2017-05-01 |
| Model Number | XOM UNK PROSTHESIS |
| Catalog Number | XOM UNK PROSTHESIS |
| 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. Other | 2017-05-01 |