FDA Adverse Event
Injury
Summary report: N
BIOHORIZONS EXTERNAL DENTAL IMPLANT
MDR report key: 819402
·
Received February 14, 2007
Report
- Report Number
- 1060818-2007-00007
- Event Type
- Injury
- Date Received
- February 14, 2007
- Date of Event
- November 15, 2006
- Manufacturer
- BIOHORIZONS IMPLANT SYSTEMS, INC.
- Product Code
- DZE
- PMA / PMN Number
- K030463
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 REASON OF REMOVAL AS DEHISCENCY AND NO PRIMARY STABILITY RELATED TO PATIENT BONE QUALITY AND QUANTITY.
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 | S1006021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other |