MAUDE MDR 9392162
- MDR report key
- 9392162
- Report number
- 3001617766-2019-05560
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-10-04
- Date received
- 2019-11-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 116
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS ADRIENNE STOTT
- Address
- 3050 EAST HILLCREST DRIVE THOUSAND OAKS CA 91362 US
- Phone
- 818-818-8184
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LEGACY 2 IMPLANT | DENTAL IMPLANT | IMPLANT DIRECT SYBRON MANUFACTURING LLC | DZE | 824713 | 107713 | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-11-30 | 0 | 1. R |
Event Narratives#
No narrative records found.