FDA Adverse Event
Injury
Summary report: N
RESTORE 3.75X13 SELF-TAP+
MDR report key: 160137
·
Received April 1, 1998
Report
- Report Number
- 2184002-1998-00223
- Event Type
- Injury
- Date Received
- April 1, 1998
- Date of Event
- December 16, 1997
- Report Date
- March 31, 1998
- Manufacturer
- LIFECORE BIOMEDICAL, INC.
- Product Code
- DZE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
IMPLANT PLACED 7/18/1997. IT FAILED TO INTEGRATE AND WAS REMOVED 12/16/97. ONE PERSON AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE 3.75X13 SELF-TAP+ Implant | ENDOSSEOUS IMPLANT | DZE | LIFECORE BIOMEDICAL, INC. | R9010-38-13 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |