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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 SYSTEM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733858
Device Problem Imprecision (1307)
Patient Problems Tissue Damage (2104); Injury (2348)
Event Date 11/13/2018
Event Type  Injury  
Manufacturer Narrative
A manufacturer representative went to the site to test the equipment. It was reported that the issue was not able to be replicated/confirmed. No components were replaced. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. 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 there was an alleged inaccuracy during the navigate task of a spinal fusion procedure. During an l1 to l5 fixation, the l4 and l5 screws were found to be misplaced. The first intervention was a dlif without navigation. The second phase was a fixation from l1 to l5 with navigation. L1 to l3 were placed correctly while the navigation was showing the good orientation. At the 2nd 3d scan for control it was noticed that the 4 screws of l4-l5 were misplaced. A third 3d scan to replace the screw with navigation was done. The fourth 3d scan of control showed that the screw was still misaligned. A fifth 3d scan was performed to realign the l5 screw. The 3d scan of control looked okay. There was a delay to the procedure of 1 hour or longer. There was no reported impact on patient outcome.
 
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Brand NameSTEALTHSTATION S7 SYSTEM
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 Key8154562
MDR Text Key130025377
Report Number1723170-2018-06201
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K050438
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 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733858
Device Catalogue Number9733858
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/12/2018 Patient Sequence Number: 1
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