FDA Adverse Event
Death
Summary report: N
ABUTMENT:SHLD,2MM,OMNILOC,4.0
MDR report key: 39079
·
Received September 23, 1996
Report
- Report Number
- 2023141-1996-00061
- Event Type
- Death
- Date Received
- September 23, 1996
- Date of Event
- August 19, 1996
- Report Date
- August 26, 1996
- Manufacturer
- CALCITEK
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
AN ABUTMENT BROKE IN FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABUTMENT:SHLD,2MM,OMNILOC,4.0 Implant | SCREW RETAINED DENTAL ABUTMENT | DZE | CALCITEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |