FDA Adverse Event
Injury
Summary report: N
LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
MDR report key: 8702060
·
Received June 14, 2019
Report
- Report Number
- 2023950-2019-00317
- Event Type
- Injury
- Date Received
- June 14, 2019
- Date of Event
- May 20, 2019
- Report Date
- June 14, 2019
- Manufacturer
- ZEST ANCHORS, LLC
- Product Code
- DZE
- UDI-DI
- 00840481101526
- PMA / PMN Number
- K120198
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
NON-INTEGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 493703 | LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) | ENDOSSEOUS DENTAL IMPLANT | DZE | ZEST ANCHORS, LLC | 07456 | I1XME | 00840481101526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |