MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAVLOCK UNIVERSAL ORANGE TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9734907
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not provided due to japanese patient privacy regulations.Device lot number, or serial number, unavailable at the time of filing.Device manufacture date is not available at time of filing.No parts have been returned to the manufacturer for analysis.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.The issue occurred preoperatively while verifying instruments and caused no delay to the surgery.It was reported that the orange tracker was getting caught when attached to probes.A different tracker was used to complete the surgery.There was no impact on patient outcome.

• Brand Name: NAVLOCK UNIVERSAL ORANGE TRACKER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7660048
• Report Number: 1723170-2018-03131
• Device Sequence Number: 2629251
• Product Code: OLO
• UDI-Device Identifier: 00763000057879
• UDI-Public: 00763000057879
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: Physician
• Device Catalogue Number: 9734907
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1