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

Model Number S7

Device Problem Imprecision (1307)

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

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.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 l3-l4 percutaneous spinal fusion, an imprecision was observed.It was reported that following placement of the screws via a robotic system, a confirmation image acquisition found that the screws were breaching by about four millimeters in the lateral direction.The screws were then revised utilizing the same image acquisitions.After repositioning, the confirmation found that the screw was off 2-3 millimeters laterally.The second screw previously placed was found to be placed accurately.After a final image acquisition, the screw was found to be placed accurately.It was noted that the imprecision was at the l3 level while l4 was accurate.There was a reported delay to the procedure of twenty minutes due to this issue.There was no impact on patient outcome.No additional information was provided.

Manufacturer Narrative

Correction: the event reported in this 3500a also represents a potential accidental radiation occurrence (aro) per 21 cfr 1002.20(a).Per 21 cfr 1002.20(c), this event is being reported under part 803.Supplemental aro information is as follows: nature and circumstances of aro: see initial mdr submission.Location of aro: 1723170.Manufacturer: see initial mdr submission.Brand name: see initial mdr submission.Number of persons exposed: 1.Number of persons adversely affected: 0.Actions taken to control, correct, or eliminate: see narrative above and/or previous mdr submissions.

Event Description

It was also reported that there was one unused spin.

• 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: heather davis ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7175717
• MDR Text Key: 96754091
• Report Number: 1723170-2018-00116
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2016
• 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
• Treatment: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 71