MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Imprecision (1307); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Iatrogenic Source (2498)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

Patient identifier not available from the site.A medtronic representative went to the site to test the equipment.The representative reported that the navigation system functioned as designed.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

Event Description

A site representative reported that, while in a cervical spinal fusion, the screw placed in the c3 vertebrae slightly breached the vertebral foramen.The screw was then removed and the remaining screws were placed a c-arm.It was noted that the reference frame came loose after the image acquisition.The surgeon stated that the reported issue was not related to the navigation system, as the patient had soft/loose bone and the head might have moved relative to the mounting point of the reference frame.Accuracy was deemed acceptable prior to placing the screw.The surgeon opted to complete the procedure without the use of the navigation system.The surgeon opted to complete the procedure without the use of the imaging system.There was a reported delay to the procedure of less than 1 hour due to this issue.No additional information was provided.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7112627
• MDR Text Key: 94668277
• Report Number: 1723170-2017-05112
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention