FDA Adverse Event
Other
Summary report: N
BIOLOK
MDR report key: 113824
·
Received August 11, 1997
Report
- Report Number
- 1045056-1997-04704
- Event Type
- Other
- Date Received
- August 11, 1997
- Report Date
- August 6, 1997
- Manufacturer
- BIO LOK INTL.
- Product Code
- DZE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
FAILED IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOLOK Implant | SCREW IMPLANT | DZE | BIO LOK INTL. | IHSSTP410 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |