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

Catalog Number 9734590

Device Problems Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information not provided due to (b)(6) patient privacy regulations.Device manufacturing date is unavailable at this time.No parts have been received by the manufacturer for evaluation.No parts returned for analysis.

Event Description

Information was received from a manufacturer representative regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that the grey nav lock tracker was not recognized.There was no reported delay to the procedure due to this issue and there was no reported impact on patient outcome.

• Brand Name: NAVLOCK TRACKER UNIVERSAL GREY
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7405958
• MDR Text Key: 104745578
• Report Number: 1723170-2018-01521
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00643169085534
• UDI-Public: 00643169085534
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/08/2018

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
• Device Operator: Physician
• Device Catalogue Number: 9734590
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1