FDA Adverse Event
Injury
Summary report: N
SST 4X10 HA CYLINDER
MDR report key: 35933
·
Received August 26, 1996
Report
- Report Number
- 2184002-1996-00157
- Event Type
- Injury
- Date Received
- August 26, 1996
- Date of Event
- May 2, 1996
- Report Date
- August 26, 1996
- Manufacturer
- LIFECORE BIOMEDICAL, INC.
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
IMPLANT WAS PLACED ON 3/13/92. PT: HEAVY BRUXISM. PT REPORTED PAIN ON CHEWING FOR SEVERAL MONTHS TO GENERAL DENTIST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SST 4X10 HA CYLINDER Implant | ENDOSSEOUS IMPLANT | DZE | LIFECORE BIOMEDICAL, INC. | 411020-40-10 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |