FDA Adverse Event
Injury
Summary report: N
ASTRA TECH
MDR report key: 2081804
·
Received May 5, 2011
Report
- Report Number
- MW5020502
- Event Type
- Injury
- Date Received
- May 5, 2011
- Manufacturer
- ASTRA
- Product Code
- DZE
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
ASTRA TECH - FRACTURED DENTAL X3. DATES OF USE: (B)(6) 2006 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: MISSING TOOTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASTRA TECH | DENTAL IMPLANTS | DZE | ASTRA | 4.5 X 11 | 31145 | |
| 2 | ASTRA TECH | DENTAL IMPLANTS | DZE | ASTRA | 4.5 X 11 | 31145 | |
| 3 | ASTRA TECH | DENTAL IMPLANTS | DZE | ASTRA | 4.5 X 9 | 29387 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |