FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 3181732
·
Received June 21, 2013
Report
- Report Number
- 1723170-2013-00462
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- February 11, 2013
- Report Date
- February 11, 2013
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
PATIENT INFORMATION WAS NOT AVAILABLE FROM THE SITE. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER.
Additional Manufacturer Narrative · 1
SOFTWARE INVESTIGATION COMPLETED. THIS ISSUE WILL BE CONTINUALLY MONITORED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A DLIF MULTI-LEVEL SPINE CASE, THE SURGEON REPORTED A SLIGHT ALIGNMENT ISSUE WITH THE IMAGES WHEN NAVIGATING INTERBODY TRIALS ON L2/L3. IT WAS REPORTED TO BE MORE PRONOUNCED WITH THE GREATER THE OBLIQUE ANGLE OF THE O-ARM SPIN. THE WORK-AROUND WAS TO TAKE ANOTHER SPIN AND ENSURE THAT THE ORIENTATION WAS TRUE A/P LATERAL. THIS ISSUE HAD NO EFFECT ON THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO IMPACT ON THE OUTCOME OF THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282145 | STEALTHSTATION S7 SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | S7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | O-ARM 1000 IMAGING SYSTEM |