MAUDE Adverse Event Report: MAZOR ROBOTICS LTD MAZOR X SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number TPL0059

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 03/22/2024

Event Type  Injury  

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that during a pediatric scoliosis surgery, the surgeon planned a t3-l2 scan and plan workflow and the surgeon exposed t2-l3.After exposure, the surgeon freehanded the left l2 screw and placed a fiducial marker in lamina at t10 (lamina is a technique the surgeon uses to help verify accuracy).The spinous process clamp was attached on the spinous process of l2 and connected the surgical arm to the patient with a standard bridge.The airframe was placed with a double spinous process clamp at t3 and t4.A 3define scan snapshot with navigation airframe was then performed.The star marker was placed and a successful imaging spin was taken.The spin was transferred to the guidance system via thumb drive.The surgeon assisted with screw planning ¿ it was planned at t8-l1 on the left side (l2 was placed freehand prior) and planned t8-l2 on the right.The surgeon started placing screws robotically at left l1 and working cranially to t8.They were periodically checking the robotic and navigation accuracy on patient's anatomy, the divot on the arm guide, and robotically by sending the arm to a trajectory planned to the fiducial marker that the surgeon placed prior to the imaging system spin.All checks successfully showed that the accuracy was intact.During instrumentation of the left side, at the t9 and t8 levels, the patient coded and had a medical emergency.The robot was detached from the patient and removed from the bed emergently.The patient was flipped to a stretcher and medical care was administered.The patient later was transferred to the pediatric intensive care unit (picu).The patient had a ct done as well as many other diagnostic tests.Per surgeon, the ct did not show any errant screw placements and the drill mark from "midas for mazor 3.0 x 30mm" drill could be seen with in the pedicle at t8 on the left.The surgery was aborted.Additional information received from a manufacturer representative reported the patient experienced low blood pressure, being pulseless, and fully coding.Cpr and blood transfusions were administered.The surgery was completed at a later date.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MAZOR X SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 1 haeshel street. (building c); caesarea business park; caesarea hefa,il 30798 30; IS 3079830
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 1 haeshel street. (building c); caesarea business park; caesarea hefa,il 30798 30; IS 3079830
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19124547
• MDR Text Key: 340378052
• Report Number: 3005075696-2024-00049
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290115751376
• UDI-Public: 07290115751376
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 28 KG