FDA Adverse Event
Other
Summary report: N
STEALTHSTATION
MDR report key: 972045
·
Received December 31, 2007
Report
- Report Number
- 1723170-2007-00012
- Event Type
- Other
- Date Received
- December 31, 2007
- Date of Event
- October 11, 2007
- Report Date
- December 31, 2007
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METHODS: ON SITE TRAINING WITH SURGEON. RESULT- SURGEON MISINTERPRETED STEREOTACTIC NAVIGATION SCREEN.
Description of Event or Problem · 1
SURGEON REPORTED TO A FIELD REP ON 12/04/2007 THAT DURING A NAVIGATED LEVEL ONE FUSION SPINAL SURGERY ON APPROX TWO MONTHS BEFORE, A POST OPERATIVE SCAN SHOWED THE SCREW LOCATION WAS IN THE VERTEBRAL FORAMEN OR DISC SPACE. THE SCREW WAS THEN REDIRECTED INTO THE PEDICLE OF THE VERTEBRAL BODY. PT IS COMPLAINING OF LEG PAIN. REPEATED ATTEMPTS AT AQUIRING PT AGE, SEX AND WEIGHT HAVE BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION | STEREOTACTIC SURGICAL SYSTEM | HAW | MEDTRONIC NAVIGATION, INC. | TRIA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |