• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735665
Device Problem Imprecision (1307)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Manufacturer Narrative
Continuation of concomitant medical products: product id: 9735740, software version: 1. 2. 0, ubd: unknown, udi#: unknown. No products have been returned to medtronic for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure. It was reported that there was an alleged inaccuracy. One level case, two screws were put it in and were accurate. Saved reverse projections off the navigated pedicle access kit (pak) needle. The left side was accurate. The right side was inaccurate while starting to tap l4. The axial appeared accurate, and the other views were off. An x-ray was performed to confirm the area where the surgeon was tapping was accurate. It just appeared inaccurate in trajectory 2, synthetic lateral, and probes eye navigation views. This issue occurred intra-operatively and caused a surgical delay of less than one hour. There was no impact on patient outcome.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13026034
MDR Text Key286647901
Report Number1723170-2021-02913
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2021
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-