FDA Adverse Event
Injury
Summary report: N
RESTORE 4X15 SELF-TAPPING IMPLANT WITH MOUNT
MDR report key: 199325
·
Received November 30, 1998
Report
- Report Number
- 2184002-1998-00840
- Event Type
- Injury
- Date Received
- November 30, 1998
- Date of Event
- November 4, 1998
- Report Date
- November 30, 1998
- Manufacturer
- LIFECORE BIOMEDICAL, INC.
- Product Code
- DZE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
FOUR IMPLANTS WERE PLACED 05/02/1998. IMPLANT IN SITE #19 DID NOT INTEGRATE AND WAS REMOVED 11/04/1998. THE OTHER 3 IMPLANTS ARE OK. ONE PERSON AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE 4X15 SELF-TAPPING IMPLANT WITH MOUNT Implant | ENDOSSEOUS IMPLANT | DZE | LIFECORE BIOMEDICAL, INC. | R9010-40-15 | 75981519 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |