FDA Adverse Event
Malfunction
Summary report: N
OPEN SPINE CLAMP, TITANIUM
MDR report key: 2061570
·
Received March 16, 2011
Report
- Report Number
- 1723170-2011-00666
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- February 21, 2011
- Report Date
- February 21, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SERIAL NUMBER IS NOT AVAILABLE AT THIS TIME. DEVICE MANUFACTURE DATE IS NOT AVAILABLE AT TIME OF THIS REPORT. RMA ISSUED.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED, THE STARBURST CONNECTOR SCREW AT THE OPEN SPINE CLAMP LOOSENS EASILY FROM THE REFERENCE FRAME AFTER WORKING 1, 2 ATTEMPTS OF PEDICLE SCREWS DURING SURGERY. THE SURGEON HAS TO RE-TIGHTEN THE STARBURST CONNECTOR SCREW AGAIN AND RE-TAKE 3D SCAN IN ORDER TO CONTINUE WITH NAVIGATION. THE SURGEON COMPLETED THE SURGERY WITH THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPEN SPINE CLAMP, TITANIUM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |