FDA Adverse Event
Injury
Summary report: N
IMPLANT 3.5X9
MDR report key: 576070
·
Received February 17, 2005
Report
- Report Number
- 9681239-2005-00001
- Event Type
- Injury
- Date Received
- February 17, 2005
- Date of Event
- January 2, 2003
- Report Date
- February 17, 2005
- Manufacturer
- INNOVA LIFE SCIENCES CORP.
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
IN 2003 A PT EXPERIENCED A FAILURE OF OSSEOINTEGRATION INVOLVING A DENTAL IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANT 3.5X9 | ENDOSSEOUS DENTAL IMPLANT | DZE | INNOVA LIFE SCIENCES CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other | NONE SPECIFIED. |