MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-11-30 for VITEK INC. manufactured by Vitek, Inc..
[1391519]
Pt received tmj vitek implant. Pt now suffers from ms-like symptoms, teflon material in vitek has eaten through the skull. Vitek implant removed in 1984. Recently had a tumor removed behind eye. Tumor contained pieces of teflon. Pt suffers from a seizure disorder as a result of the tmj implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5013766 |
| MDR Report Key | 1550698 |
| Date Received | 2009-11-30 |
| Date of Report | 2009-11-30 |
| Date Added to Maude | 2009-12-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK INC. |
| Generic Name | VITEK |
| Product Code | JAZ |
| Date Received | 2009-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VITEK, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention; 3. Deathisabilit | 2009-11-30 |