FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2152472
·
Received June 28, 2011
Report
- Report Number
- 1723170-2011-01159
- Event Type
- Malfunction
- Date Received
- June 28, 2011
- Date of Event
- June 13, 2011
- Report Date
- June 14, 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
EXAM NOT NEEDED. ERROR WAS DUE TO REFERENCE FRAME MOVEMENT.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THAT DURING A T4-T11 SCOLI O-ARM NAVIGATED FUSION PROCEDURE. THE SURGEON NOTICED A 3MM INACCURACY WITH THE NAVIGATION SUPERIOR AND LATERALLY. THE SURGEON OPTED TO STOP USING NAVIGATION FOR THE ONE FINAL SCREW AND PLACED IT WITH FLUORO. THEY USED FLUORO AND NIM MONITORING TO TEST ALL NAVIGATED SCREW PLACEMENTS AND HE CONFIRMED THEY WERE ALL GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | TREON | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | O ARM 1000 IMAGING SYSTEM |