FDA Adverse Event
Injury
Summary report: N
ABUTMENT: SHOULDERED 2MM INTEGRAL 3.25
MDR report key: 43623
·
Received October 22, 1996
Report
- Report Number
- 2023141-1996-00174
- Event Type
- Injury
- Date Received
- October 22, 1996
- Date of Event
- September 18, 1996
- Report Date
- September 25, 1996
- Manufacturer
- CALCITEK
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS MEDWATCH REPORT #2023141-1996-000173.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABUTMENT: SHOULDERED 2MM INTEGRAL 3.25 Implant | SCREW RETAINED DENTAL ABUTMENT | DZE | CALCITEK | NA | 961339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |