FDA Adverse Event
Injury
Summary report: N
BIOHORIZONS INTERNAL DENTAL IMPLANT
MDR report key: 819416
·
Received February 14, 2007
Report
- Report Number
- 1060818-2007-00010
- Event Type
- Injury
- Date Received
- February 14, 2007
- Date of Event
- November 23, 2006
- Manufacturer
- BIOHORIZONS IMPLANT SYSTEMS, INC.
- Product Code
- DZE
- PMA / PMN Number
- K042429
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE IMPLANT WAS NOT FRACTURED. THE IMPLANT WAS EXAMINED UNDER 20X MAGNIFICATION AND NO THREAD DEFECTS WERE NOTED. THE IMPLANT UNIT RETURNED WAS WITHIN SPECIFICATION.
Description of Event or Problem · 1
REMOVAL OF DENTAL IMPLANT. THE CLINICIAN REPORTED THE IMPLANT WAS PLACED AND REMOVED THE SAME DAY BECAUSE OF NO PRIMARY STABILITY WHEN INSERTING THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOHORIZONS INTERNAL DENTAL IMPLANT | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | BIOHORIZONS IMPLANT SYSTEMS, INC. | NA | S0406035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |