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

Catalog Number	9734907
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not made available from the site.Device lot number not available.(b)(6).Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested.Replacement navlock universal orange tracker shipped to site 09/27/2016.No parts have been received by manufacturer for analysis.No further issues have been reported.
Event or Problem Description
A site representative alleged that while in a spinal fusion procedure, navigation using their navlock universal orange tracker was inaccurate.No specific measurement, or direction, of the alleged inaccuracy was provided.No further details regarding this issue, or specifically when it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.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: 5993335
• Report Number: 1723170-2016-02445
• Device Sequence Number: 569972
• Product Code: OLO
• UDI-Device Identifier: 00643169091047
• UDI-Public: 00643169091047
• Combination Product (Y/N): N
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2016

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 Catalogue Number: 9734907
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2016
• Initial Report FDA Received Date: 10/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1