FDA Adverse Event
Malfunction
Summary report: N
CLAMP, THORACIC, RADIOLUCENT
MDR report key: 2021362
·
Received February 8, 2011
Report
- Report Number
- 1723170-2011-00100
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 11, 2011
- Report Date
- January 11, 2011
- Manufacturer
- MEDTRONIC NAVIGATION
- 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 PATIENT INFORMATION AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. DEVICE NOT YET RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
A SITE REPRESENTATIVE REPORTED THAT A THORACIC SPINE CLAMP HAD A STRIPPED SCREW. NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLAMP, THORACIC, RADIOLUCENT | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION | NA | 100201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NONE |