FDA Adverse Event
Malfunction
Summary report: N
INCLUSIVE TAPERED IMPLANT 3.7 X 11.5MM
MDR report key: 3842852
·
Received June 2, 2014
Report
- Report Number
- 3002195199-2014-00030
- Event Type
- Malfunction
- Date Received
- June 2, 2014
- Date of Event
- February 21, 2014
- Report Date
- June 2, 2014
- Manufacturer
- PRISMATIK DENTALCRAFT, INC.
- Product Code
- DZE
- PMA / PMN Number
- K121406
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
DR. PLACED IMPLANT IN #14 SITE. PATIENT CAME BACK TWO WEEKS LATER AND IT HAD FAILED TO OSSEOINTEGRATE. IMPLANT WAS EXPLANTED.
Description of Event or Problem · 1
DR. PLACED IMPLANT IN #3 AFTER BONE GRAFTING. PRIMARY STABILITY. IMPLANT STARTED TO BE 'REJECTED' AND SHOWED THROUGH GINGIVAL AND LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320877 | INCLUSIVE TAPERED IMPLANT 3.7 X 11.5MM | ENDOSSEOUS DENTAL IMPLANT | DZE | PRISMATIK DENTALCRAFT, INC. | 6004083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |