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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SURETRAK II UNIVERSAL TRACKER, SMALL PASSIVE FIGHTER ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SURETRAK II UNIVERSAL TRACKER, SMALL PASSIVE FIGHTER ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9731567
Device Problem Calibration Problem (2890)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/03/2018
Event Type  malfunction  
Manufacturer Narrative
Unique device identification (udi) is not available. Device lot number, or serial number, unavailable. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. No parts have been received by the manufacturer for evaluation.
 
Event Description
Medtronic received information regarding a navigation system. It was reported that intra/peri-operatively during the navigate task of a sacroiliac and thoracolumbar procedure, the site used an orange tracker and a driver and it was accurate, however; during the case calibration was lost. The site chose to use a tracker with the grey on the driver. The site stated it wasn't loose and after investigating the orange tracker it had been heavily used. There was no delay to the procedure. No known impact on patient outcome.
 
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Brand NameSURETRAK II UNIVERSAL TRACKER, SMALL PASSIVE FIGHTER
Type of DeviceORTHOPEDIC 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
prashanth gali
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7718500
MDR Text Key115065014
Report Number1723170-2018-03687
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K983670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 07/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9731567
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2018
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

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