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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC THORACIC PROBE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734403
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 10/29/2019
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. The unique identifier was not available at the time of reporting. The thoracic probe was returned to the manufacture for evaluation. After visual/physical examination the reported issue was confirmed. The tip of the returned probe was bent as twisted. The manufacture date was not available at the time of reporting. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported outside of a procedure that the site had multiple damaged instruments. The clamp was stuck on the tracker. The tracker was stuck on a medium clamp. The driver tip was bent. The probe had a twisted tip. A clamp had a screw broken off. No patient was present at the time of the event.
 
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Brand NameTHORACIC PROBE
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 Key9453028
MDR Text Key184704653
Report Number1723170-2019-05969
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K124004
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
Report Date 12/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734403
Device Catalogue Number9734403
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2019
Was Device Evaluated by Manufacturer? Yes
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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