MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734590
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 for a cervical spine procedure.It was reported that with one set of trackers, the navigation was off and accuracy could not be maintained immediately after the imaging spins.The vertek arm attachments and small passive frame attachments were checked and it was made sure that nothing was pushing up against the frame.After re-spinning, tracking was still inaccurate.The trackers were swapped out after the 3rd spin, and everything was accurate.The auto-registration method was used.The amount of inaccuracy was estimated to be 5mm lateral to midline and 7mm anterior to the actual starting point.There was a less than one hour delay to the procedure, and the impact to patient outcome was unknown at the time of the event.
Additional Manufacturer Narrative
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 system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from a manufacturer representative indicated there was no impact to the patient outcome.The trackers were not be returned as the account wanted to keep them.The manufacturer representative tested the trackers at the account and returned them to the hospital.

• Brand Name: NAVLOCK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8962123
• Report Number: 1723170-2019-04755
• Device Sequence Number: 2687771
• Product Code: OLO
• UDI-Device Identifier: 00763000054403
• UDI-Public: 00763000054403
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171267
• 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,Followup
• Report Date (Section B): 09/23/2019

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: No Information
• Device Model Number: 9734590
• Device Catalogue Number: 9734590
• Device Lot Number: 180713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 62