FDA Adverse Event
Other
Summary report: N
NAV CD HORIZON SOLERA 4.75MM DRIVER
MDR report key: 2914453
·
Received January 14, 2013
Report
- Report Number
- 1723170-2012-00713
- Event Type
- Other
- Date Received
- January 14, 2013
- Date of Event
- November 12, 2012
- Report Date
- November 12, 2012
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
PATIENT INFO NOT PROVIDED AS THE SITE'S NEURO COORDINATOR STATED THEY WIL NOT RELEASE DEMOGRAPHIC INFO. LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE AT TIME OF THIS REPORT. DEVICE MANUFACTURE DATE IS DEPENDENT ON LOT NUMBER, OR SERIAL NUMBER, AND NOT AVAILABLE AT THIS TIME. SUSPECT PART HAS NOT BEEN RETURNED TO MANUFACTURER FOR EVALUATION. NO INFO REGARDING DISPOSITION OF SUSPECT PART HAS BEEN MADE AVAILABLE.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SURGERY, THE STANDARD SOLERA DRIVER TWISTED AT THE TIP. THE PROCEDURE WAS COMPLETED WITH THE USE OF STEALTHSTATION S7 SYSTEM. THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21618 | NAV CD HORIZON SOLERA 4.75MM DRIVER | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | SOLERA STANDARD SCREWDRIVER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |