FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2193642
·
Received July 13, 2011
Report
- Report Number
- 1723170-2011-01221
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- June 24, 2011
- Report Date
- June 24, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINE SURGERY, THE SURGEON WAS INACCURATE BY 4MM LATERAL. THEY SUCCESSFULLY TOOK A SPIN AND EVERYTHING SEEMED TO BE GOOD. THE SURGEON USED THE PAK NEEDLE FOR INSERTING GUIDE WIRES, AND BROUGHT THE O-ARM BACK IN TO COMPLETE ANTERIOR, POSTERIOR, AND LATERAL IMAGES, AT THIS POINT, THEY ALLEGED THEY WERE OFF BY 4 MM. THE SURGEON DISCONTINUED THE USE OF THE O-ARM AND COMPLETED THE PROCEDURE. 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 | 51 YR | O-ARM 1000 IMAGING SYSTEM |