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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL SEE H10)

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL SEE H10) Back to Search Results
Model Number S7
Device Problems Imprecision (1307); Use of Device Problem (1670)
Patient Problems Perforation (2001); Spinal Column Injury (2081)
Event Date 05/22/2018
Event Type  Injury  
Manufacturer Narrative
Patient information not provided due to (b)(6) patient privacy regulations. No procode, common device name, unique device identification (udi) and/or 510k provided as this device is not released for distribution in the united states. A software analysis was initiated. However, the software evaluation found that a probable cause was unable to be determined.
 
Event Description
Medtronic received information regarding a navigation system being used during a cervical spine procedure. It was reported that when a c7 pendicle screw was inserted,the screw was misplaced. While checking the direction by the system's pointer, a pilot hole was created using a regular instrument. The screw was then displaced from the pendicle when it was inserted, and therefore the screw was removed. It was reported that the screw was inserted by an assistant physician, and the screw driver slid and hit the dura mater while the screw was being implanted. The dura mater was damaged and sutured. The event occurred intra/perioperatively with less than one hour delay to surgical time. There was no impact on patient outcome but one screw was misplaced and had to be removed.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that the reported issue could not be replicated. The system then passed the system checkout and was found to be fully functional.
 
Manufacturer Narrative
Patient weight was refused by the reporter.
 
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Brand NameCART 9734056 S7 STAFF SHRT 100-120V INTL
Type of DeviceSEE H10)
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
stephanie riley
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7620183
MDR Text Key111706489
Report Number1723170-2018-02883
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberS7
Device Catalogue Number9734056
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/20/2018 Patient Sequence Number: 1
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