FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2172149
·
Received June 24, 2011
Report
- Report Number
- 1723170-2011-01151
- Event Type
- Malfunction
- Date Received
- June 24, 2011
- Date of Event
- June 8, 2011
- Report Date
- June 8, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K040438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE MANUFACTURE DATE UNKNOWN. SOFTWARE FINDINGS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED INACCURACY DURING A SPINE CASE WITH THE S7 NAVIGATION SYSTEM. THE SURGEON PLACED SCREWS IN L4 AND L5 SUCCESSFULLY ON THE PATIENT'S RIGHT SIDE. WHEN THE SURGEON WENT TO THE LEFT SIDE, THE NAVIGATION WAS OFF "4-5MM SUPERIORLY." THE SURGEON ELECTED TO DISCONTINUE USE OF THE O-ARM, AND WAS USING A C-ARM. NO IMPACT ON THE PATIENT'S OUTCOME WAS REPORTED.
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 | 75 YR | O-ARM 1000 IMAGING SYSTEM |