FDA Adverse Event
Injury
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 1910584
·
Received November 19, 2010
Report
- Report Number
- 1723170-2010-00067
- Event Type
- Injury
- Date Received
- November 19, 2010
- Date of Event
- October 21, 2010
- Report Date
- October 21, 2010
- Manufacturer
- MEDTRONIC NAVIGATION
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SYSTEM WAS EVALUATED AT THE SITE. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED BY A MEDTRONIC REPRESENTATIVE. THE SYSTEM WAS FULLY FUNCTIONAL AND THE SYSTEM CHECKOUT SHOWED NO ANOMALIES.
Description of Event or Problem · 1
MEDTRONIC REPRESENTATIVE REPORTED THAT A PT HAD THE L5 RIGHT SCREW NOT INSERTED CORRECTLY AND REQUIRED A REVISION. SITE REPRESENTATIVE REPORTED THAT IT WAS NOT AN ISSUE WITH NAVIGATION, BUT WITH THE PLACEMENT OF THE SCREW. REVISION SURGERY COMPLETED WITHOUT ISSUE. PT REPORTED TO BE DOING GREAT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION | TREON | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |