FDA Adverse Event
Malfunction
Summary report: N
ETIII SA DENTAL IMPLANT
MDR report key: 9921294
·
Received April 3, 2020
Report
- Report Number
- 3007135442-2020-00002
- Event Type
- Malfunction
- Date Received
- April 3, 2020
- Report Date
- April 3, 2020
- Manufacturer
- HIOSSEN, INC.
- Product Code
- DZE
- PMA / PMN Number
- K140934
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 |
|---|---|---|---|---|---|---|---|
| 382909 | ETIII SA DENTAL IMPLANT | DENTAL IMPLANT | DZE | HIOSSEN, INC. | AET3R4011S | H1E13J030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |