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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 PREMIUM SYSTEM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 PREMIUM SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735665
Device Problem Imprecision (1307)
Patient Problems Complaint, Ill-Defined (2331); Iatrogenic Source (2498); No Known Impact Or Consequence To Patient (2692)
Event Date 01/31/2019
Event Type  Injury  
Manufacturer Narrative
A manufacturer representative went to the site to test the equipment. The navigation system passed the system checkout and was f ound to be fully functional. No parts on the system were replaced. 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 during a complex t4 to l3 fusion, the surgeon claimed 4 screws were inaccurately placed. The site used 2 spins with the frame placed on l3 and t9. Accuracy was verified with the passive planar probe. The screws on the cad model looked slightly off. It was noted that a knock-off driver was being used with knock-off screws. The patient had very small pedicles but the screws were relatively large. The screws were replaced with use of a c-arm. There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.
 
Manufacturer Narrative
A software analysis was initiated to determine the probable cause of the issue through reproducibility. Analysis was unable to determine probable cause without further information since the on-going investigation proved to be inconclusive based on the information provided. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A software analysis was initiated to determine the probable cause of the issue. Analysis found that the logs were reviewed and provided no additional insight into the alleged inaccuracy. Based on the case description that knock-off driver/screws were used, this is the likely cause. These tools are not supported by the stealth application (outside the use of suretrak, which was not used) and we cannot guarantee the accuracy of their driver. This is further supported by the fact that the passive planar was accurate while the screw placement was not. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTEALTHSTATION S8 PREMIUM 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 Key8384350
MDR Text Key137665373
Report Number1723170-2019-00866
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
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 Received06/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2018
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: 03/02/2019 Patient Sequence Number: 1
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