FDA Adverse Event
Malfunction
Summary report: N
SOLERA STANDARD DRIVER
MDR report key: 2081488
·
Received April 19, 2011
Report
- Report Number
- 1723170-2011-00877
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 23, 2011
- Report Date
- March 23, 2011
- Manufacturer
- MEDTRONIC 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 LOT NUMBER AND DEVICE MANUFACTURE DATE WERE UNK AS NO LOT NUMBER WAS PROVIDED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. INFO WAS PROVIDED TO THE MEDTRONIC REPRESENTATIVE REGARDING HOW TO ATTACH THE DRIVER AND SCREW TO MINIMIZE TOGGLE.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED AN ISSUE DURING A SURGERY. THE DOCTOR FELT THAT THE DRIVER DID NOT HOLD THE SCREW SECURELY OR RIGIDLY, WHICH ALLOWED FOR TOGGLE AS HE WAS IMPLANTING THE SCREW. THE SURGEON COMPLETED THE SURGERY WITH THE USE OF THE STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM. THERE WAS NO IMPACT ON THE PT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLERA STANDARD DRIVER | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |