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

Model Number TPL0059

Device Problems Imprecision (1307); Calibration Problem (2890)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2022

Event Type  malfunction  

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that there were deviations during a l3-l5 fusion case.The surgeon felt the trajectories were 1-2mm deviated from the plan in navigation.Another snapshot was done and the surgeon felt the system was accurate with the navigation probe so they proceeded with the case.All left side trajectories looked like they were 1-2 mm medial to plan in axial view and accurate in the lateral screw.The left side screws were 1-2 mm lateral to plan, but still within the pedicle.All right side trajectories looked accurate in axial view and 1-2 mm superior to plan in the lateral view.Implanted screws on the right side were accurate.No screws were explanted or repositioned and neuromonitoring was done for safety.There was no patient harm and the procedure was delayed less than an hour.

Manufacturer Narrative

Other relevant device(s) are: product id: m728894b252, serial/lot #: none, product id: asm0207-02s , serial/lot #: none.A medtronic representative went to the site to test the equipment.Testing revealed that all screws on the positioner were tight, the surgical arm passed a stress, accuracy and bist test, and all tools failed the navigation test with the angle between plan and instrument readings high, but in specification.The back shoulder adjustment screw was stripped and the brake test failed.The shoulder was replaced.The system then passed the system checkout and was found to be fully functional.Analysis results were not available as of the date of this report.A follow up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: analysis of the navigation software found there was insufficient information if the software contributed to the event.Camera reported multiple times infrared interference error on the tools there was an instance of "algorithm limitation error" from the ndi localizer.It is not known whether these are related to the complaint.There are no warnings, errors, or other information in the logs that appear to provide more information for the cause of the problem.Analysis of the shoulder found the complaint was confirmed.Visual/physical examination found physical damage and the adjustment scr ew was stripped.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: 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.Due to the fact that in the export received left side screws were already placed, planning could not be examined.Since right side screws were deemed accurate, there was no reason to check the planning for these screws.Comparison of left side screws planning and execution was possible as the screws were present within the images.Left l3 and left l4 were accurate to plan, left l5 was slightly lateral due to entry angle but within acceptable range.No post op images were provided for right side screws.Images were not provided to show the navigation problem.On the left side, screws were accurately placed by the guidance system although seemed off in navigation.This was solved once with a snapshot but repeated later when right side screws were executed.Since the screws were positioned according to plan, surgical arm inaccuracy can be ruled out for this case.After ruling out surgical arm inaccuracy as a possi ble causes for the reported variance, analysis concluded that the reported navigation inaccuracy was due to a mobile reference frame, possibly due to the plastic residues in the connecting points.Analysis results of the shoulder were not available as of the date of this report.A follow up report will be submitted when analysis is complete.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 13854134
• MDR Text Key: 288119147
• Report Number: 3005075696-2022-00029
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109184838
• UDI-Public: 07290109184838
• 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,Followup,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: No
• 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: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• 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: "SEE H10...."
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 54 KG