FDA Adverse Event
Injury
Summary report: N
MS SA IMPLANT
MDR report key: 17856323
·
Received October 2, 2023
Report
- Report Number
- 3003394081-2023-00001
- Event Type
- Injury
- Date Received
- October 2, 2023
- Report Date
- August 29, 2022
- Manufacturer
- OSSTEM IMPLANT CO., LTD.
- Product Code
- DZE
- PMA / PMN Number
- K122171
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DENTAL IMPLANT FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1099168 | MS SA IMPLANT | DENTAL IMPLANT | DZE | OSSTEM IMPLANT CO., LTD. | MSN2510S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |