FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC
MDR report key: 1701726
·
Received May 24, 2010
Report
- Report Number
- MW5016088
- Event Type
- Malfunction
- Date Received
- May 24, 2010
- Date of Event
- March 15, 2010
- Report Date
- May 24, 2010
- Manufacturer
- MEDTRONIC
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
TIP OF A MEDTRONIC 3D PEDICLE PROBE BROKE IN THE PT'S VERTEBRAL BODY OF THE LEFT L 5 PEDICLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC | PEDICLE PROBE | LXH | MEDTRONIC | 836-034 | BM517784 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |