FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2062087
·
Received March 17, 2011
Report
- Report Number
- 1723170-2011-00673
- Event Type
- Malfunction
- Date Received
- March 17, 2011
- Date of Event
- February 21, 2011
- Report Date
- February 21, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PT INFO NOT AVAILABLE AT THIS TIME. EVAL OF THE DEVICE HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THAT THE SITE CALLED HIM TO REPORT THAT THEY WERE INACCURATE 4 CM AFTER ATTEMPTING 2 NAVIGATED 3D SPINS. THE SURGEON DECIDED TO DISCONTINUE USE OF THE O-ARM AND STEALTH AND USED A C-ARM BY ITSELF FOR THE CASE. THERE WAS NO IMPACT ON THE PT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION S7 SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | S7 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |