FDA Adverse Event
Injury
Summary report: N
LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
MDR report key: 13790606
·
Received March 16, 2022
Report
- Report Number
- 2023950-2022-00151
- Event Type
- Injury
- Date Received
- March 16, 2022
- Report Date
- April 6, 2022
- Manufacturer
- ZEST ANCHORS, LLC
- Product Code
- DZE
- UDI-DI
- 00840481101540
- PMA / PMN Number
- K120198
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
LOOS OF INTEGRATION. LOSS OF INTEGRATION, TOOTH 25.
Description of Event or Problem · 0
LOOS OF INTEGRATION. LOSS OF INTEGRATION, TOOTH 25.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 779643 | LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) | ENDOSSEOUS DENTAL IMPLANT | DZE | ZEST ANCHORS, LLC | 07460 | I1Y3V | 00840481101540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| H |