FDA Adverse Event
Malfunction
Summary report: N
CLAMP, THORACIC, RADIOLUCENT
MDR report key: 1932174
·
Received December 14, 2010
Report
- Report Number
- 1723170-2010-00176
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- November 15, 2010
- Report Date
- November 15, 2010
- Manufacturer
- MEDTORNIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION OF THE DAMAGED PART FOUND THAT THE MALFUNCTION DIRECTLY CAUSED EVENT. THE RETURNED PART SHOWED SIGNS OF WEAR AND TEAR. THE CLAMP FACE WAS SLIGHTLY BENT TO ONE SIDE. THE ADJUSTMENT SCREW THREADS WERE STRIPPED AT THE TOP OF THE TRAVEL.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SCREW WAS STRIPPED IN THE THORACIC RADIOLUCENT CLAMP. THERE WAS NO PT PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLAMP, THORACIC, RADIOLUCENT | STEREOTAXIC SYSTEM (HAW) | HAW | MEDTORNIC NAVIGATION, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NONE |