FDA Adverse Event
Other
Summary report: N
IMPLANT: HA, INTEGRAL
MDR report key: 67083
·
Received February 7, 1997
Report
- Report Number
- 2023141-1997-00043
- Event Type
- Other
- Date Received
- February 7, 1997
- Date of Event
- August 1, 1995
- Report Date
- January 9, 1997
- Manufacturer
- CALCITEK
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IN A LEGAL COMPLAINT, PLAINTIFF-PT ALLEGES AN IMPLANT FAILED. INFO FROM MEDWATCH REPORT #1010478.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANT: HA, INTEGRAL Implant | HA CYLINDER ENDOSSEOUS DENTAL IMPLANT | DZE | CALCITEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |