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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK 9736060 BLACK ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC NAVLOCK 9736060 BLACK ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9736060
Device Problems Imprecision (1307); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a guidance system being used during a spinal procedure. It was reported that navigation was inaccurate during a l4-s1 tlif procedure. The surgeon used an open, midline approach and a unilateral workflow starting on the left side and then moving to the right side. Navigation tools were placed down the arm guide and they were off trajectory. The drill, tap and screws were off. Navigation was off by 3-3. 5 mm in the axial and lateral views. The accuracy of the surgical arm was checked with the passive planar probe being placed on the divot, and the arm was accurate. Anatomical checks were also accurate. The surgeon continued to use the guidance system to place screws. C-arm images were taken before and after placement and the screws were placed accurately. A new snapshot was not taken until the reference frames were switched from the robotic reference frame to the stealth air frame for the tlif portion due to the passive planar looking accurate when testing the divot on the arm guide as well as when nav igating to known anatomical landmarks. There was no patient harm and the procedure was delayed less than an hour. Additional information received from a manufacturer representative reported that they suspected the inaccuracy was due to the instruments as several o ther cases were completed successfully with a different instrument tray.
 
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Brand NameNAVLOCK 9736060 BLACK
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14135707
MDR Text Key289521288
Report Number1723170-2022-00583
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K124004
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
Report Date 04/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9736060
Device Catalogue Number9736060
Device Lot Number210722
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2019
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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