FDA Adverse Event
Other
Summary report: N
STEALTHSTATION TREON SYSTEM
MDR report key: 1757047
·
Received July 13, 2010
Report
- Report Number
- 1723170-2010-00030
- Event Type
- Other
- Date Received
- July 13, 2010
- Date of Event
- June 30, 2010
- Report Date
- July 1, 2010
- Manufacturer
- MEDTRONIC NAVIGATION
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATED ON SITE BY A MEDTRONIC EMPLOYEE. AT THE TIME OF THIS REPORT, ACCURACY ISSUE CANNOT BE DUPLICATED.
Description of Event or Problem · 1
INACCURATE SPINE SCREW PLACEMENT REPORTED (B)(6) 2010 FOR PROCEDURE ON (B)(6) 2010 DURING SURGERY WITH THE STEALTHSTATION TREON SYSTEM AND O ARM SYSTEM. SURGEON OPERATED ON L4 AND L5; TWO SCREWS WERE PLACED ACCURATELY AND THEN AFTER SWITCHING SIDES, THE THIRD SCREW WAS PLACED INACCURATELY, WENT INTO THE DISC SPACE AND HIT A NERVE. THE NERVE WENT TO THE RIGHT FOOT, HOWEVER, THE PT JUST HAD THEIR RIGHT LEG AMPUTATED BELOW THE KNEE. THE SURGEON REPORTED THAT NAVIGATION WAS INACCURATE TO THE LEFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION TREON SYSTEM | STEREOTAXIC SYSTEM (HAW) | HAW | MEDTRONIC NAVIGATION | TREON | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention | O-ARM SYSTEM |