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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2021

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that three of six screws placed with the guidance system were deviated laterally and placed in the spinal canal and foramen.The screws were deviated between 3.5 and 10 mm.The cause of the deviation was not determined.A revision procedure was done to reposition the screws freehand.There was no patient harm.

Manufacturer Narrative

H3: analysis of the software export was complete.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.Analysis reviewed the planning made in the or.No issues were found with planning.The provided post-op image showed right l5 to be lateral-superior and left l5 medial.According to the representative, s1 left was also deviated but was corrected intraoperative.As reported, the patient was obese.Moreover, joint 4 failure was alerted twice.In the first time there was a shoulder shift due to which a re-registration took place.The second overspeed error, which indicated a force applied on the robotic arm, appeared in the logs after l4 and s1 screws were executed and before l5.Combined with the deviation nature which fits a patient shift and the patient's high bmi, waterbed effect and tool pressure of the surgeon while leaning on the patient is most likely the cause of the misplaced trajectories.Analysis reviewed the planning and the surgical workflow and concluded the root cause of the deviation experienced in the or is patient shift occurred while drilling, due to a waterbed effect.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.

Event Description

Additional information received from a manufacturer representative reported that the case was minimally invasive.The case was started successfully, but at the second screw, the screwdriver was stuck on the screw and the surgeon pulled out the screw with too much force causing a shoulder shift.At this point, s1 and l5 right side screws were already placed.A new registration was done, but the surgical arm had problems reaching the other trajectories due to the screw extenders.The surgeon was also not happy with the right l5 screw so they removed they removed both l5 screws and decided to start from the beginning.The right l5 was too medial and the left l5 was too lateral and superior.The s1 left screw was deviated so the planning was changed intraoperatively due to the patient being obese and the collision with the extenders of l5 and pelvis.The patient experienced issues two weeks after surgery.Navigation was checked and everything was okay.

• Brand Name: MAZOR X STEALTH EDITION
• 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
• MDR Report Key: 11821803
• MDR Text Key: 258133973
• Report Number: 3005075696-2021-00055
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109183213
• UDI-Public: 07290109183213
• Combination Product (y/n): N
• PMA/PMN Number: K182077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• 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: 04/29/2021
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention