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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problem Insufficient Information (4580)

Event Date 04/21/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: asm0206, serial/lot #: (b)(4), udi#: (b)(4). A medtronic representative went to the site to test the equipment. Testing revealed that surgical arm pass and accuracy, navigation and built in self test, but failed the stress test at j5. A field motor calibration of the surgical arm was done and the arm then passed all testing. The system then passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure. It was reported that there was a deviation during a l3-l5 spinal fusion case. Ct-fluoro registration and 3define scan were completed without issue. An accuracy check on the arm guide passed. After successful setup, the surgical arm was sent to left l3. The surgeon placed the screw and the neuromonitoring dipped during placement. The screw was removed and the surgeon used a pedicle finder to determine the location. After checking the hole location, the placed the screw and neuromonitoring was triggered again. The surgeon removed the screw and checked the hole with a pedicle finder again. The surgeon determined there was a lateral breach. The screw was placed manually without the surgical arm. The surgeon decided to restart the setup and registration process with the guidance system. Setup was completed without issue using two new flouro images. The surgical arm was sent to left l4 and an accuracy check was done. The surgical arm failed the accuracy check so the surgeon decided to abort the use of the guidance system and complete the procedure using navigation. The procedure was delayed over an hour.

• Brand Name: MAZOR X SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IS 3079567
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IS 3079567
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14245808
• MDR Text Key: 290451311
• Report Number: 3005075696-2022-00041
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse