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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK TRACKER UNIVERSAL VIOLET ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC NAVLOCK TRACKER UNIVERSAL VIOLET ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734682
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 11/30/2018
Event Type  malfunction  
Manufacturer Narrative
Device lot number and udi number are unavailable. Initial reporter information unavailable at the time of filing. No parts have been returned to the manufacturer for analysis. Device manufacturing date is unavailable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used outside of a procedure. It was reported that the instrument was broken during the sterilization process. There was no patient present when this issue was observed.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the navlock was broken where we press to release the tap and the navlock was attached to the tap when the issue occurred. It was stated that it was not possible to separate them.
 
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Brand NameNAVLOCK TRACKER UNIVERSAL VIOLET
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8204794
MDR Text Key131721125
Report Number1723170-2018-06508
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K171267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734682
Device Catalogue Number9734682
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2019
Was Device Evaluated by Manufacturer? No
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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