FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION S7 SYSTEM
MDR report key: 2043317
·
Received February 25, 2011
Report
- Report Number
- 1723170-2011-00168
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- January 28, 2011
- Report Date
- January 28, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS IN PROGRESS.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT THE 1ST SPIN TAKEN AND TRANSFERRED TO THE STEALTHSTATION (S7) FROM THE O-ARM WAS INACCURATE. THE SITE THEN DID ANOTHER SPIN AND THE SURGEON FELT ACCURATE. THERE WAS 1 UNUSED SPIN. THE SURGEON COMPLETED THE CASE WITH THE S7 AND THERE WAS NO INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION S7 SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | S7 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |