FDA Adverse Event
Injury
Summary report: N
BIOHORIZONS INTERNAL DENTAL IMPLANT
MDR report key: 819115
·
Received February 14, 2007
Report
- Report Number
- 1060818-2007-00005
- Event Type
- Injury
- Date Received
- February 14, 2007
- Date of Event
- January 8, 2007
- Manufacturer
- BIOHORIZONS IMPLANT SYSTEMS, INC.
- Product Code
- DZE
- PMA / PMN Number
- k042429
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- 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 ABUTMENT WAS EVALUATED AND EASY TO REMOVE AFTER ABUTMENT SCREW WAS REMOVED. REMOVAL TORQUE FROM ABUTMENT SCREW WAS MEASURED, 17.0 N-CM. THE DEVICE HISTORY RECORD WAS REVIEWED AND VERIFIED THAT THE IMPLANT AND ACCOMPANYING ABUTMENT MET SPECIFICATION.
Description of Event or Problem · 1
REMOVAL OF DENTAL IMPLANT. THE CLINICIAN REPORTED THE IMPLANT WAS REMOVED BECAUSE THE ABUTMENT COULD NOT BE TAKEN OUT AND PLACED ANOTHER 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 | S0606023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |