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

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.

• Brand Name: CART 9734056 S7 STAFF SHRT 100-120V INTL
• Type of Device: SEE 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 Key: 7620183
• MDR Text Key: 111706489
• Report Number: 1723170-2018-02883
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10)
• Number of Events Reported: 1
• 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 Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: S7
• Device Catalogue Number: 9734056
• 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 Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2015
• 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