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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735667
Device Problems Mechanics Altered (2984); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2022
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. 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 being used in a spinal fusion procedure. It was reported that the threaded screw fixation on the screw head was being used with the screwdriver. While being used it loosens while screwing the screw into the patient, because the soft tissue of the patient is in contact with the outer part of the screwdriver. This causes the navigation to loose precision, since the screwdriver and screw then have some clearance. To prevent loosening, the health care professional has to tighten the screw fixation several times while screwing in. The probable cause of the reported issue was thought to be the screwdriver design. The next step was to possibly change the design of the screwdriver and use a locking device as used with the non navigated screwdriver. To prevent the screw head fixation from unscrewing screwdriver. There was no delay to the case. No impact on patient outcome. Additional information was received stating that clarification was received stating that "causes the navigation to loose precision" mean that the navigation relies on the fact that the screwdriver and screw are tightened coaxial together. If the screw loosens physically and gets some angle to the screwdriver it defers from its virtual projection in the navigation. The health care professional (hcp) tightened the fixation between screw and screwdriver several times while inserting making it straight again. This didn't lead to any misplaced screws it just felt insecure. The hcp mentioned the desire for a locking device.
 
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Brand NameSTEALTHSTATION¿ S8 SYSTEM
Type of DeviceNEUROLOGICAL 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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13524951
MDR Text Key286597764
Report Number1723170-2022-00193
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735667
Device Catalogue Number9735667
Device Lot NumberN30513605
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/14/2021
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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