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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAV 5.5MM TAP (CANNULATED) ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC NAV 5.5MM TAP (CANNULATED) ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734239
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 tap was bent and was attached to a navlock when the issue occurred.
 
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Brand NameNAV 5.5MM TAP (CANNULATED)
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 Key8204830
MDR Text Key131720980
Report Number1723170-2018-06509
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K124004
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 Number9734239
Device Catalogue Number9734239
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 Received03/21/2019
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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