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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problem Nerve Damage (1979)

Event Date 04/25/2022

Event Type  Injury  

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 scan plan l1-l4 fusion trans-facial procedure.The surgical system was mounted to the patient using a spinal process clamp at l2.Rigidity was checked by the surgeon and they felt the mount was solid.Bilateral retraction was very light and used on the skin.The patient had fractures at l2 and l3.There was a 2 cm shift during the procedure.The left l1 screw went lateral and the right l1 screw went through the canal.The screws were removed.Seven spins were taken to identify the deviation.The surgeon decided to abort the use of the guidance system and place screws at l1 using navigation.The procedure was delayed an hour.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The surgical arm passed a built in self test, advanced accuracy, stress, and trajectory tests.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 images in order to inspect and understand procedure workflow.Analysis reviewed the planning made for the case and the planning made in the or.No evidence of lateral or medial skiving potential was found.Analysis reviewed the matching accuracy of the system.The ct-fluoro matching of the vertebrae were determined acceptable with green values.Post-op image provided show left screw to be lateral to plan outside of the vertebral body, and right screw to be translated approximately 10 mm medial to plan.Post-op images provided show screws to be lateral and inferior to plan.As l1 trajectories were the only trajectories executed, platform or patient shift cannot be ruled out.Trauma fractures and presumably ligament raptures can be observed in l2 and l3.Mounting on a fractured spine may compromise the stability of the platform.According to the rep the platform used was "the single sp clamp out of the older bone mount tray.The one that tightens with a wing nut." intra-op scan shows the clamp used was the mis clamp.The mini clamp is designated to be attach to the mist or link bridge with further anchoring to the spine (and not separately).A schanz bond (can be seen in the 3d reconstruction) is for the schanz screw.Such platform assembly is not recommended.Furthermore, sizes are specifically fit for each platform assembly to assure best stability, connecting them otherwise may lead to platform instability.The system completed a bist test successfully before the surgery, and a full system check was performed.Analysis reviewed all the available information and concluded the root cause of the deviations of left and right l1 to be a platform shift due to the unstable anatomy on which the platform was mounted, combined with an incorrect selection and assembly of platform.Mounting the system onto a mobile spine due to significant axial fractures with presumed ligamentous injuries, combined with the use of the mini-clamp led to an unstable platform which moved whenever a slight force was used.If information is provided in the future, a supplemental report will be issued.

• 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: 14347644
• MDR Text Key: 291316586
• Report Number: 3005075696-2022-00043
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109183213
• UDI-Public: 07290109183213
• 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: Physician
• Type of Report: Initial
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2019
• 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): Other
• Patient Age: 17 YR
• Patient Sex: Female