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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL SEE H10)

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL SEE H10) Back to Search Results
Model Number S7
Device Problem Imprecision (1307)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2016
Event Type  malfunction  
Manufacturer Narrative
Site dr. (b)(6) declined to provide patient information. No procode, common device name and/or 510(k) provided as this device is not released for distribution in the united states.   return requested. Replacement navlock universal gray tracker and navlock universal violet tracker were both shipped to site 11/11/2016. No parts have been received by manufacturer for analysis. No further issues have been reported.
 
Event Description
A medtronic representative reported that, while in a spine procedure, on alleged an inaccuracy of approximately 1 -2 millimeters occurred. The surgeon was using a navlock universal gray tracker and a navlock universal violet tracker and could not confirm there was any damage to either instrument. 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.
 
Manufacturer Narrative
Investigation of returned suspect navlock universal violet tracker and navlock universal gray tracker finds that both trackers were found to be in good condition with no apparent physical damage. With a known good awl tip inserted and markers attached, the trackers returned good geometry and divot error readings. No problem found. The reported event could not be duplicated by medtronic personnel.
 
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Brand NameCART 9734056 S7 STAFF SHRT 100-120V INTL
Type of DeviceSEE H10)
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
kristianna bilan
826 coal creek circle
louisville, CO 80027-9710
7208902338
MDR Report Key6153491
MDR Text Key62216165
Report Number1723170-2016-05670
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 01/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9734056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2015
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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