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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735665
Device Problems Imprecision (1307); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/07/2020
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 9735740, serial/lot #: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system used during a sacroiliac and thoracolumbar procedure. It was reported that during the case, while using the infinity instruments, the screw width and length would be adjusted but the computer-aided design (cad) model would not reflect this. They had to switch out the instrument in the tracker then switch back to the infinity before the cad model would update. There was a delay of less than one hour and no impact to the patient.
 
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Brand NameSTEALTHSTATION S8 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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10513800
MDR Text Key206347679
Report Number1723170-2020-02405
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 12/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2019
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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