FDA Adverse Event
Injury
Summary report: N
RESTORE 5X8 SELF-TAPPING IMPLANT WITH MOUNT
MDR report key: 196597
·
Received November 13, 1998
Report
- Report Number
- 2184002-1998-00790
- Event Type
- Injury
- Date Received
- November 13, 1998
- Report Date
- November 13, 1998
- Manufacturer
- LIFECORE BIOMEDICAL, INC.
- Product Code
- DZE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IMPLANT PLACED 12/18/1997. IT FAILED AND WAS REMOVED 3-6 MONTHS AFTER PLACEMENT, DATE UNKOWN, DUE TO SCAR TISSUE FORMATION, INFECTION, MOBILITY PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE 5X8 SELF-TAPPING IMPLANT WITH MOUNT Implant | ENDOSSEOUS IMPLANT | DZE | LIFECORE BIOMEDICAL, INC. | R9010-50-08 | 75971582 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |