FDA Adverse Event
Injury
Summary report: N
KLOCKNER DENTAL IMPLANTS
MDR report key: 540710
·
Received August 19, 2004
Report
- Report Number
- 9617542-2004-00002
- Event Type
- Injury
- Date Received
- August 19, 2004
- Date of Event
- April 19, 2004
- Report Date
- August 13, 2004
- Manufacturer
- SOADCO, S.L.
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IMPLANT PLACED BETWEEN "MENTONIANS." REMOVAL OF THE IMPLANT DUE TO A SPRAIN CAUSED BY THE POOR PLACING OF THE MOVABLE PROSTHESIS BY THE PT. THE DENTURE WAS PLACED FIXED IN A SINGLE BALL JOINT, THIS WAS NOT NOTICED AND CAUSED THE LESION WHICH LED TO THE REPLACEMENT OF THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KLOCKNER DENTAL IMPLANTS | DENTAL IMPLANT | DZE | SOADCO, S.L. | 543710 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |