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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC LEFT THORACIC TACTILE PROBE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734436
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 11/12/2019
Event Type  malfunction  
Manufacturer Narrative
Name of initial reporter unknown at the time of filing. No parts have been received by the manufacturer for evaluation. 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 that the site found that the instrument tip was bent while cleaning the it. There was no patient present when this issue was identified.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received additional information that the instrument could not be verified.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received clarification that the damaged instrument was discovered by a manufacturer representative.
 
Manufacturer Narrative
The probe was returned to the manufacturer for analysis. Analysis found that the tip of the returned probe was bent. However, with a tracker attached, the probe returned good geometry and divot error readings with normal tracking. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameLEFT THORACIC TACTILE 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 Key9416631
MDR Text Key182996095
Report Number1723170-2019-05875
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,Followup,Followup,Followup
Report Date 02/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734436
Device Catalogue Number9734436
Device Lot Number170907
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2017
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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