FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2152474
·
Received June 28, 2011
Report
- Report Number
- 1723170-2011-01161
- Event Type
- Malfunction
- Date Received
- June 28, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 9, 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'S WEIGHT IS UNAVAILABLE FROM THE SITE. NO PART HAS BEEN RETURNED. RMA SUBMITTED FOR REPLACEMENT BREAK OUT BOX.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THAT THEY WERE ABLE TO TRACK THE O-ARM TRACKER AND INSTRUMENTS BUT UNABLE TO TRACK THE ACTIVE SPINE FRAME. THEY TRIED AN ADDITIONAL ACTIVE SPINE FRAME; NO EFFECT. THEY THEN BROUGHT IN ANOTHER CAMERA WHICH WAS ABLE TO TRACK THE FRAME AND THE CASE PROCEEDED AS PLANNED. NO IMPACT ON PT OUTCOME WAS REPORTED.
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 | 41 YR |