FDA Adverse Event
Malfunction
Summary report: N
TRIA PLUS
MDR report key: 1930252
·
Received November 18, 2010
Report
- Report Number
- 1723170-2010-00081
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- October 20, 2010
- Report Date
- October 20, 2010
- Manufacturer
- MEDTRONIC NAVIGATION
- Product Code
- HAW
- PMA / PMN Number
- K001153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO PT INFO AS THE EVENT DID NOT OCCUR DURING SURGERY. VERTEK ARM WAS RETURNED FOR EVAL. THE VERTEK ARM TIGHTENED AND RELEASED WITHOUT ISSUE. THE RETURNED DEVICE WAS FOUND TO BE FULLY FUNCTIONAL. THE REPORTED EVENT COULD NOT BE DUPLICATED BY PRODUCT SERVICES PERSONNEL.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THAT THE VERTEK ARM WAS UNABLE TO BE TIGHTENED. THERE WAS NO PT PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIA PLUS | STEREOTAXIC SURGICAL SYSTEM (HAW) | HAW | MEDTRONIC NAVIGATION | TRIA | 793821 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NONE |