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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) THORACIC PROBE TIP; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) THORACIC PROBE TIP; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9734403
Device Problems Bent (1059); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information not provided due to japanese patient privacy regulations.Device lot number, or serial number, unavailable at the time of filing.Device manufacture date is not available at time of filing.No parts have been returned to the manufacturer for analysis.
 
Event Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that the lumbar probe was deformed.There was no delay in surgery and no impact on patient outcome.
 
Manufacturer Narrative
Additional information: device lot number and manufacture date provided.
 
Manufacturer Narrative
The lumber probe was returned to the manufacturer for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.The tip of the returned probe was bent and there were impact marks at the back causing fit issues with the mating tracker.Physical damage was found.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that the lumbar probe was deformed.There was no delay in surgery and no impact on patient outcome.
 
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Brand Name
THORACIC PROBE TIP
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
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
peter verhey
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7658961
MDR Text Key113044768
Report Number1723170-2018-03108
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00763000053796
UDI-Public00763000053796
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K124004
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,Followup
Report Date 12/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue Number9734403
Device Lot Number140214
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received07/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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