FDA Adverse Event
Injury
Summary report: N
MINIMARK DENTAL IMPLANT SYSTEM
MDR report key: 3213857
·
Received July 3, 2013
Report
- Report Number
- 1287163-2013-00076
- Event Type
- Injury
- Date Received
- July 3, 2013
- Date of Event
- March 12, 2013
- Report Date
- June 28, 2013
- Manufacturer
- ACE SURGICAL SUPPLY CO.
- Product Code
- DZE
- PMA / PMN Number
- K092594
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. IMPLANT WAS PLACED ON (B)(6) 2013 IN THE SITE #22 (TYPE II BONE). PRIMARY STABILITY WAS ACHIEVED. THE CLINICIAN STATES THE IMPLANT WAS A SPINNER. THE IMPLANT WAS REMOVED ON (B)(6) 2013 DUE TO MOBILITY. MED. HISTORY NO SIGNIFICANT FINDINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303706 | MINIMARK DENTAL IMPLANT SYSTEM | 2.3X13 W 2MM CUFF MINIMARK IMPLANT | DZE | ACE SURGICAL SUPPLY CO. | 11231320 | 11070098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |