FDA Adverse Event
Malfunction
Summary report: N
INCLUSIVE TAPERED IMPLANT 4.7 X 10MM
MDR report key: 3980903
·
Received August 5, 2014
Report
- Report Number
- 3002195199-2014-00049
- Event Type
- Malfunction
- Date Received
- August 5, 2014
- Date of Event
- July 8, 2014
- Report Date
- July 8, 2014
- Manufacturer
- PRISMATIK DENTALCRAFT, INC.
- Product Code
- DZE
- PMA / PMN Number
- K121406
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
IMPLANT FAILURE - TOOTH #14.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 457278 | INCLUSIVE TAPERED IMPLANT 4.7 X 10MM | ENDOSSEOUS DENTAL IMPLANT | DZE | PRISMATIK DENTALCRAFT, INC. | 6004060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |