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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC N/A INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC N/A INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number TPL0038
Device Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/18/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a guidance system being used during a spinal procedure. It was reported that there was a deviation on l5 on the right side and deviations on l4 and l5 on the left side. One screw was accurate and three were misplaced. No revisions were complete. No additional information was able to be retrieved from the facility.
 
Manufacturer Narrative
Clinical export data files were inspected and after eliminating planning and registration shifts, the investigating team has reviewed all available information and concluded the root cause of the deviations to be patient movement/shift, as all trajectories were deviating in the same manner. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameN/A
Type of DeviceINSTRUMENT, STEREOTAXIC
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 Key9484525
MDR Text Key177383849
Report Number1723170-2019-06064
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTPL0038
Device Catalogue NumberTPL0038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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