FDA Adverse Event
Malfunction
Summary report: N
ET SYSTEM
MDR report key: 9084164
·
Received September 18, 2019
Report
- Report Number
- 3007135442-2019-00006
- Event Type
- Malfunction
- Date Received
- September 18, 2019
- Date of Event
- June 18, 2019
- Report Date
- August 30, 2019
- Manufacturer
- HIOSSEN, INC.
- Product Code
- DZE
- PMA / PMN Number
- K140934
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
DENTAL IMPLANT FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 877086 | ET SYSTEM | DENTAL IMPLANT | DZE | HIOSSEN, INC. | ET3R4011S | H1E12K020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |