FDA Adverse Event
Injury
Summary report: N
INFINITY DENTAL IMPLANT SYSTEM
MDR report key: 3020609
·
Received March 21, 2013
Report
- Report Number
- 1287163-2013-00031
- Event Type
- Injury
- Date Received
- March 21, 2013
- Date of Event
- October 25, 2012
- Report Date
- March 20, 2013
- Manufacturer
- ACE SURGICAL SUPPLY CO., INC.
- Product Code
- DZE
- PMA / PMN Number
- K954513
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. IMPLANT WAS PLACED ON (B)(6) 2012 IN SITE #10 (TYPE III BONE). PRIMARY STABILITY AND OSSEOINTEGRATION WERE ACHIEVED. A PREVIOUS GRAFT WAS PERFORMED ON (B)(6) 2012. THE CLINICIAN STATES THAT THE SITE HAD A PREVIOUSLY FAILED IMPLANT. THE CLINICIAN REPORTS THAT THE IMPLANT CAME OUT IN IMPRESSION DESPITE APPEARING TO BE INTEGRATED DURING UNCOVERY APPT. THE IMPLANT WAS REMOVED ON (B)(6) 2013. MEDICAL HISTORY: NO SIGNIFICANT FINDINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 118328 | INFINITY DENTAL IMPLANT SYSTEM | INTERNAL HEX DENTAL IMPLANT | DZE | ACE SURGICAL SUPPLY CO., INC. | 203710 | 12030031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |