FDA Adverse Event
Other
Summary report: N
BIOHORIZONS PADHH
MDR report key: 1348716
·
Received March 18, 2009
Report
- Report Number
- 1060818-2009-00002
- Event Type
- Other
- Date Received
- March 18, 2009
- Date of Event
- February 24, 2009
- Report Date
- March 18, 2009
- Manufacturer
- BIOHORIZONS IMPLANT SYSTEMS, INC.
- Product Code
- DZI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WAS RETURNED FOR EVAL. YIELDING OF THE LATCH INDICATED EXCESSIVE TORQUE HAD BEEN APPLIED TO THE PART. DEVICE HISTORY RECORD REVIEW DEMONSTRATED DEVICE MET DESIGN REQUIREMENT.
Description of Event or Problem · 1
A PART OF THE INTERNAL ABUTMENT-LEVEL DRIVER BROKE OFF IN THE ABUTMENT "RIGHT UNDERNEATH THE TIP." THE IMPLANT WAS REMOVED IN ORDER TO RETRIEVE THE BROKEN DRIVER TIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOHORIZONS PADHH | INTERNAL ABUTMENT-LEVEL DRIVER | DZI | BIOHORIZONS IMPLANT SYSTEMS, INC. | PADHH | 0801898 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |