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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC NAVLOCK ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734683
Device Problems Material Integrity Problem (2978); Mechanical Jam (2983)
Patient Problem No Patient Involvement (2645)
Event Date 07/02/2020
Event Type  malfunction  
Manufacturer Narrative
The returned tracker had evidence of slight galling inside the handle. However, a known good instrument was able to be inserted with little resistance. With markers attached and fully seated, tracker displayed good geometry and divot error readings with normal tracking. Initial reporter occupation has been requested. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that the orange tracker was discovered to be stuck on the driver in sterile processing. Once the instruments were removed, it was noted that the tracker's "inner cannula" had a catch/etching in it. There was no obvious reason found for the issue, however, both instruments look to have some initial etching. There was no patient involvement.
 
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Brand NameNAVLOCK
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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10420257
MDR Text Key204728914
Report Number1723170-2020-02199
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734683
Device Catalogue Number9734683
Device Lot Number200317
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/17/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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