• 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 LUMBAR PROBE 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 LUMBAR PROBE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734679
Device Problem Degraded (1153)
Patient Problem No Patient Involvement (2645)
Event Date 08/11/2020
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. The unique identifier was not known at the time of the event. The probe was returned to the manufacture for evaluation. After visual/physical examination the reported issue was confirmed. The returned probe had a bent tip and impact marks at the back end causing fit issues with any mating tracker. The manufacture date was not available at the time of reporting.
 
Event Description
Medtronic received information regarding a navigation device being used outside of a procedure. It was reported that the tip and the probe were defective.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLUMBAR PROBE
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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10656782
MDR Text Key211038677
Report Number1723170-2020-02671
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K124004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734679
Device Catalogue Number9734679
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-