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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION INC. STEALTH ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION INC. STEALTH ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9733623
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Migration (4003)
Patient Problems Headache (1880); Laceration(s) (1946); Dizziness (2194); Blood Loss (2597)
Event Date 05/14/2019
Event Type  Injury  
Event Description
Cervical spine surgery performed for correction of prior surgery. Headache and dizziness returned. Ct found that a screw had migrated and transected the vertebral artery resulting in bleeding. Patient also had suffered a stroke. Transferred to neuro icu. Third surgery performed to replace screw. Dizziness persists. Surgeon reports inaccuracy of equipment used on cervical cases-stealth navigation system resulted in screw placement being off. Fda safety report id # (b)(4).
 
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Brand NameSTEALTH
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION INC.
MDR Report Key8722590
MDR Text Key148998644
Report NumberMW5087507
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/18/2019
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received06/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733623
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/20/2019 Patient Sequence Number: 1
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