MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7´; INSTRUMENT, STEREOTAXIC

Model Number	9733857
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: synergy spine s7; i7 2.1 9733686, 510k k131425.A medtronic representative went to the site to test the equipment.It was reported that the issue could not be confirmed or replicated, no components were replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.A video and image of the issue was received.The software investigation was unable to determine probable cause without further information since the behavior cannot be replicated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used in a cervical spine procedure.It was reported that the image was centered in trajectory1, trajectory2, and axial; but in the sagittal view the image shifted to the top left point when the screw projection could not be seen on the c2.When the surgeon brings in the passive planar probe the image in the sagittal view stays shifted and the crosshairs move to the top left as well.When the health care professional (hcp) pushed the re-center button it resolved the issue momentarily.The hcp could move the image in the sagittal view to re-center it.The surgeon set the crosshair settings as stationary.The surgeon stated that when the procedure was planned the sagittal view was shifted as well.There was no delay to the procedure.No impact on patient outcome.

• Brand Name: STEALTHSTATION® S7´
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8719987
• Report Number: 1723170-2019-03687
• Device Sequence Number: 19429731
• Product Code: HAW
• UDI-Device Identifier: 00613994450951
• UDI-Public: 00613994450951
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9733857
• Device Catalogue Number: 9733857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR