FDA Adverse Event
Malfunction
Summary report: N
OSTEOIMPLANT TECHNOLOGY INC. BIPOLAR
MDR report key: 3112169
·
Received October 24, 2006
Report
- Report Number
- 1644408-2006-00021
- Event Type
- Malfunction
- Date Received
- October 24, 2006
- Date of Event
- September 7, 2006
- Report Date
- October 23, 2006
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- JDI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A (B)(6) FEMALE HAD THE BIPOLAR HEAD DISLOCATE FROM THE STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSTEOIMPLANT TECHNOLOGY INC. BIPOLAR | BIPOLAR | JDI | ENCORE MEDICAL, L.P. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |