FDA Adverse Event
Injury
Summary report: N
HG II FIXTURE SYSTEM
MDR report key: 3042132
·
Received April 4, 2013
Report
- Report Number
- 3007135442-2013-00007
- Event Type
- Injury
- Date Received
- April 4, 2013
- Report Date
- January 22, 2013
- Manufacturer
- HIOSSEN INC.
- Product Code
- DZE
- PMA / PMN Number
- K093352
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CROWN WAS PLACED AND IMPLANT WAS FAILED DUE TO BONE GRAFT. THE PT HAD POOR BONE QUALITY. FAILURE TO OSSEOINTEGRATE IS A WELL-KNOWN INHERENT RISK OF DENTAL IMPLANTS. THIS IS WELL DOCUMENTED IN THE LITERATURE ACROSS IMPLANT SYSTEM. IN ADDITION, FAILURE TO OSSEOINTEGRATE IS INCLUDED IN THE IFU AS A KNOWN COMPLICATION WITH VARIOUS FACTORS THAT CONTRIBUTE TO THE RISK OF IMPLANT FAILURE.
Description of Event or Problem · 1
CROWN WAS PLACED AND IMPLANT WAS FAILED DUE TO BONE GRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 138412 | HG II FIXTURE SYSTEM | DENTAL IMPLANT | DZE | HIOSSEN INC. | HG II | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |