FDA Adverse Event
Injury
Summary report: N
MINIMARK DENTAL IMPLANT SYSTEM
MDR report key: 3020610
·
Received March 21, 2013
Report
- Report Number
- 1287163-2013-00030
- Event Type
- Injury
- Date Received
- March 21, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 20, 2013
- Manufacturer
- ACE SURGICAL SUPPLY CO., INC.
- Product Code
- DZE
- PMA / PMN Number
- K092594
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. IMPLANT WAS PLACED ON (B)(6) 2013 IN SITE AREA #9. PRIMARY STABILITY WAS ACHIEVED. THE CLINICIAN STATES THAT THE IMPLANT BECAME LOOSE. THE IMPLANT WAS REMOVED ON (B)(6) 2013 DUE TO MOBILITY. MED HISTORY: DIABETES MELLITUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 117315 | MINIMARK DENTAL IMPLANT SYSTEM | 3.25 X 10 W 2MM CUFF MINIMARK IMPLANT | DZE | ACE SURGICAL SUPPLY CO., INC. | 10321020 | 12020084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |