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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MAZOR RENAISSANCE INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC MAZOR RENAISSANCE INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number TPL0038
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation team reviewed all the acquired images and the operation log of the system. It was concluded that the cause for the multiple failed registrations is cross-view error between the ap and obl images and a low image match between the ct to fluro. The cross-view error and low image match is a result of a low quality of the images acquired during the case. 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 registration filed at first attempt. The surgeon moved the 3d marker from station 5 to station 8 and a new set of images were taken. Registration did not succeed at second attempt, so a new ap image was taken. After several attempts, only t11 & t10 vertebrae were registered, so a new set of images were taken, but registration failed on all bodies with automatic, semi-automatic and manual. The surgeon decided to abort and continue free hand. There was no known impact on the patient outcome.
 
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Brand NameMAZOR RENAISSANCE
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 Key9587042
MDR Text Key175393059
Report Number1723170-2020-00144
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K152041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2020
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 Manufacturer12/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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