FDA Adverse Event
Injury
Summary report: N
ABUTMENT: SHOULDERED, 5MM, INTEGRAL, 3.25
MDR report key: 180362
·
Received August 4, 1998
Report
- Report Number
- 2023141-1998-00638
- Event Type
- Injury
- Date Received
- August 4, 1998
- Report Date
- July 7, 1998
- Manufacturer
- SULZER CALCITEK
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
DR. REPORTED THAT AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS MEDWATCH REPORTS #2023141-1998-00635, 2023141-1998-00636, AND 2023141-1998-00637.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABUTMENT: SHOULDERED, 5MM, INTEGRAL, 3.25 Implant | SCREW RETAINED DENTAL ABUTMENT | DZE | SULZER CALCITEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |