• 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 MEDTRONIC NAVIGATION ORTHOPEDIC 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 MEDTRONIC NAVIGATION ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number UNK_NAV_SYS
Device Problem Imprecision (1307)
Patient Problems Stroke/CVA (1770); Headache (1880); Hemorrhage/Bleeding (1888); Dizziness (2194)
Event Date 05/14/2019
Event Type  Injury  
Manufacturer Narrative
Patient information unavailable. Device model number, serial number, and udi unavailable. E: initial reporter and facility unknown. System was not evaluated because system and facility are unknown. If information is provided in the future, a supplemental report will be issued. [mw5087507].
 
Event Description
Medtronic received information regarding a navigation system being used for a cervical spine procedure. It was reported via medwatch form to the fda that screw placement was inaccurate after using a navigation system. The medwatch form stated a cervical spine surgery was performed for correction of a prior surgery. It was noted headache and dizziness returned. A computed tomography (ct) found a screw had migrated and transected the vertebral artery resulting in bleeding. The patient also had suffered a stroke and was transferred to neuro intensive care unit (icu). A third surgery was performed to replace screw. It was noted dizziness persisted. No further information was available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMEDTRONIC NAVIGATION
Type of DeviceORTHOPEDIC 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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key9125434
MDR Text Key161194208
Report Number1723170-2019-05024
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK_NAV_SYS
Device Catalogue NumberUNK_NAV_SYS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/26/2019 Patient Sequence Number: 1
-
-