MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC TRACKER 9734682 NAVLOCK UNIVERSAL VIOLET; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734682
Medical Device Problem Codes	Mechanical Problem (1384); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/19/2019
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 guidance system being used prior to a spinal procedure.It was reported that the trackers were damaged and would not track.The manufacturer representative reported that the issue had occurred on multiple occasions and situations.Troubleshooting was attempted, but the issue was not resolved.The cause of no tracking was not determined.No patient harm was reported.

• Brand Name: TRACKER 9734682 NAVLOCK UNIVERSAL VIOLET
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9200167
• Report Number: 1723170-2019-05252
• Device Sequence Number: 11410367
• Product Code: OLO
• UDI-Device Identifier: 00763000054298
• UDI-Public: 00763000054298
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

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: 9734682
• Device Catalogue Number: 9734682
• Device Lot Number: 190305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1