FDA Adverse Event
Malfunction
Summary report: N
PEDIGUARD
MDR report key: 1804901
·
Received August 10, 2010
Report
- Report Number
- 1804901
- Event Type
- Malfunction
- Date Received
- August 10, 2010
- Date of Event
- August 9, 2010
- Report Date
- August 10, 2010
- Manufacturer
- SPINEGUARD SA -ORGENIX LLC
- Product Code
- FZX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
Narratives
Description of Event or Problem · 1
THE DEVICE WAS ENGAGED TO BE USED. THE DEVICE STARTED BEEPING AND WOULD NOT QUIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PEDIGUARD | DRILL, PEDICLE | FZX | SPINEGUARD SA -ORGENIX LLC | * | 08461D0076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |