FDA Adverse Event
Injury
Summary report: N
BIOHORIZONS EXTERNAL DENTAL IMPLANT
MDR report key: 839019
·
Received April 11, 2007
Report
- Report Number
- 1060818-2007-00034
- Event Type
- Injury
- Date Received
- April 11, 2007
- Date of Event
- February 4, 2007
- Report Date
- April 10, 2007
- Manufacturer
- BIOHORIZONS IMPLANT SYSTEMS, INC.
- Product Code
- DZE
- PMA / PMN Number
- K030463
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORD WAS REVIEWED AND VERIFIED THAT THE IMPLANT MET SPECIFICATION.
Description of Event or Problem · 1
REMOVAL OF DENTAL IMPLANT. THE CLINICIAN REPORTED THE IMPLANT WAS PLACED AND REMOVED THE SAME DAY DUE TO NO PRIMARY STABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOHORIZONS EXTERNAL DENTAL IMPLANT | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | BIOHORIZONS IMPLANT SYSTEMS, INC. | NA | S0206002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |