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

Catalog Number	9734590
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight not available from the site.Device manufacturing date is unavailable at this time.No parts have been received by the manufacturer for evaluation.No parts returned for evaluation.
Event or Problem Description
A medtronic representative reported that while in a spinal fusion procedure the grey navlock tracker on the imaging system was damaged.The representative reported that the 'flanged broke off' of the grey navlock tracker.The broken piece was recovered.There was no delay to the procedure was a result of this issue and no impact on the patient outcome.No additional information provided.
Additional Manufacturer Narrative
Additional information: device manufacture date provided.

• Brand Name: NAVLOCK TRACKER UNIVERSAL GREY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7231064
• Report Number: 1723170-2018-00470
• Device Sequence Number: 13772194
• Product Code: OLO
• UDI-Device Identifier: 00643169085534
• UDI-Public: 00643169085534
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2018

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: 9734590
• Device Lot Number: 160714
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 02/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR