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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PAK NEEDLE KIT ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PAK NEEDLE KIT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9733498
Device Problems Imprecision (1307); Material Deformation (2976)
Patient Problems Spinal Column Injury (2081); Tissue Damage (2104)
Event Date 08/07/2018
Event Type  Injury  
Manufacturer Narrative
Manufacturing date was unavailable at the time of filing. No parts have been returned to the manufacturer for analysis. Part not returned.
 
Event Description
Medtronic received information regarding a navigation system. It was reported that during the navigate task of a sacroiliac and thoracolumbar procedure, there was an alleged inaccuracy due to a damaged navigated pedicle access needle (pac). The navigated pac needle was used for a l2-l4 posterior fixation "mis voyager procedure". The pac needle registered using a passive spine frame. The pac needle was used to find the appropriate guidewire position. After insertion of all 6 guidewires the navigated cannulated tab driver was used. Having the guidewires in place and following the acquired path with the navigated tab driver it was alleged that the path was 2mm off the actual target path. After eliminating possible errors - the nav tab and nav driver showed the same path - a new pac needle was used. That showed that the first pac needle was faulty. The site examined the faulty pac needle and it could be seen that the cannula was siting loosely in the handle - which explained why the surgeon was able to register the pac needle - not putting pressure on it. However as soon as the pac needle was within tissue the surgeon was putting pressure on it and therefore showed a different path on the navigation system than its actual path. This incident added approx 2 hours to hour case, which normally would have only taken 1. 5 hours due to the fact that the surgeon had to re-position its guidewires and two already inserted screws. The final result was good, there was no reported impact on patient outcome.
 
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Brand NamePAK NEEDLE KIT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
parker desautel
navigation customer quality
826 coal creek circle
louisville, CO 80027
MDR Report Key7851626
MDR Text Key119398756
Report Number1723170-2018-04421
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K131425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number9733498
Device Lot Number180508D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/06/2018 Patient Sequence Number: 1
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