FDA Adverse Event
Other
Summary report: N
BONE GEN TR
MDR report key: 936193
·
Received April 10, 2007
Report
- Report Number
- 1045056-2007-00003
- Event Type
- Other
- Date Received
- April 10, 2007
- Date of Event
- March 6, 2007
- Report Date
- April 4, 2007
- Manufacturer
- BIOLOK INTL., INC.
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT DID NOT DISOLVE OR ABSORB INTO THE BODY.
Description of Event or Problem · 1
THE DOCTOR INDICATED THAT THERE WERE 3 CASES, WHERE THE PRODUCT WAS NOT ABSORBED BY THE BODY AND BONE GROWTH DID NOT OCCUR. THE SITE HAD TO BE RE-GRAFTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BONE GEN TR | BONE REGENERATION SOLUTION | DZE | BIOLOK INTL., INC. | CSTR01 | 0609251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |