FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2193494
·
Received July 21, 2011
Report
- Report Number
- 1723170-2011-01236
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- July 6, 2011
- Report Date
- July 6, 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
NO PT INFO PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. RMA ISSUED FOR TWO REPLACEMENT VERTEK II ARMS, BOTH SHIPPED ON (B)(4) 2011. INVESTIGATION FINDS FIRST VERTEK ARM HANDLE HAD BEEN TURNED TOO FAR OPEN AND WAS LOCKED UP. MEDTRONIC REP WAS ABLE TO BREAK THE HANDLE LOOSE, BUT BOTH ENDS OF THE VERTEK ARE LOCKED UP; AND THE TIP OF THE ATTACHMENT SCREW IS BROKEN OFF. SECOND RETURNED PART, FOUND BOTH ENDS OF THE VERTEK LOCK AND RELEASE WITH THE HANDLE. NO VISIBLE DAMAGE. NO PROBLEM FOUND. SECOND VERTEK ARM IS FULLY FUNCTIONAL.
Description of Event or Problem · 1
A SITE PURCHASING REP REPORTED TWO DAMAGED VERTEK ARMS IN NEED OF REPLACEMENT. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM | STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | TREON | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |