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

Model Number TPL0059

Device Problems Imprecision (1307); Use of Device Problem (1670)

Patient Problem Muscle Weakness (1967)

Event Date 03/15/2022

Event Type  Injury  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment. Testing revealed that the event was unable to be replicated. The system then passed the system checkout and was found to be fully functional. Analysis of the software exports and logs found the complaint was confirmed. Clinical export data file was thoroughly inspected. The log file was examined with respect to all intraoperative fluoro images in order to inspect and understand procedure workflow. Fluoro images were checked and 3d registration was attempted with the registration 3d marker images utilized during the operation on a mazor rd workstation. Analysis reviewed the ct study used in the or. No issues were found with the ct study parameters chosen. Two registration attempts were made, both were unsuccessful. Automatic segmentation was achieved in both attempts. When examining the ap and obl images taken, it can be seen that the cages between l3 and l4 and between l4 and l5 are brighter than the vertebras, and the alif between l5 and s1 is obstructing anatomical landmarks in the ap and obl image. In addition, low quality fluoro images decreased the ability to recognize the existing anatomical landmarks. Log file examination showed registration failed for l5, passed with yellow values for l4 and s1 and passed with green values on l3. Eventually registration failed due to 50% rule (in case half of the vertebras are not green all vertebras will be reduced to a lower degree, green -> yellow, yellow -> red). Analysis concluded the root cause of the registration failure experienced is low image match between the ct and the fluoro, due to new hardware inserted, obstructing the anatomy and low quality fluoro images. 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 were registration issues during a l3-s1 olif open procedure. A 3 level olif was performed with lateral plate at l5/s1 prior to registration. The system would not register l4-s1, but l3 had yellow values. The ct scan used did not have cages or plates in it. The manufacturer representative tried manual registration and using multiple images without success. A new oblique image was acquired, but registration was still unsuccessful. Screws were placed at l3, but the surgeon decided to bring in an o-arm and place screws at l4-s1 using a scan <(>&<)> plan workflow. The s1 screw was found to be medial during the procedure. The trajectory was re-planned and was placed accurately. The procedure was delayed less than an hour. A post-op ct scan showed that the right l3-l5 screws were all medial. The screws were deviated 5. 5 to 6. 5 mm on average. The patient was experiencing weakness in their right leg. A revision procedure was done using the guidance system.

• 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: 14007043
• MDR Text Key: 288905231
• Report Number: 3005075696-2022-00030
• 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
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• 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: 04/04/2022 Patient Sequence Number: 1