FDA Adverse Event
Injury
Summary report: N
VARI-ANGLE HIP SCREW (VHS) SYSTEM
MDR report key: 1162923
·
Received September 18, 2008
Report
- Report Number
- 2242816-2008-00131
- Event Type
- Injury
- Date Received
- September 18, 2008
- Date of Event
- August 25, 2008
- Report Date
- September 10, 2008
- Manufacturer
- EBI, L.P.
- Product Code
- KTT
- PMA / PMN Number
- K964880
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED HIP PAIN AFTER A FALL. IT WAS DISCOVERED THAT THE IMPLANTED VHS SCREW HAS FRACTURED. THE SCREW WAS REMOVED AND REPLACED WITH A NEW SCREW AND PLATE. PATIENT STATUS IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VARI-ANGLE HIP SCREW (VHS) SYSTEM | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | KTT | EBI, L.P. | 199837 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |