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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

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 an error message that the surgical arm was off trajectory was displayed for right l2.The manufacturer representative thought this was likely due to skiving.There were no error or warning messages for left l3, and the trajectory was deviated and not in the planned position.The surgeon removed the left l3 screw.The surgical arm was resent to the trajectory with the same planning and the screw was able to be accurately placed.Screws were placed in the following order during the procedure: left l4, right l4, left l3, right l3, right l2 and left l2.There was no patient harm and the procedure was delayed over an hour.

Event Description

Additional information received from a manufacturer representative reported the screws were deviated between 3.5-10 mm.The cause of the right l2 screw deviation was skiving.The cause of the left l3 screw was unknown.All screws were placed in the pedicle except for left l3 which was lateral, not in the pedicle, but in the vertebral body.The patient was doing well with no sensory or other issues reported besides graft site pain.

Manufacturer Narrative

H3: analysis results 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.

Manufacturer Narrative

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 left l3 did not skive, but right l3 and left l2 skived cranially.Intra-op x-rays showed the deviations.The representative noted that the surgical arm was on trajectory when the error message for l2 was received.Left l3 was positioned correctly.Right l3 was replaced with the original trajectory and the screw was placed accurately.Left l2 was re-planned with a new trajectory and was repositioned.Right l3 was placed in two different positions even though the registration and plan was the same.

Manufacturer Narrative

H3: analysis of the software export was completed.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 workstation.Analysis reviewed the planning of the case.It can be seen that skiving potential can be noticed on the superior-inferior plane of l2 right and l3 left, the entry point is at a triangular tip which can result in either superior or inferior skiving for entry point deviation of >1.5mm.The registration was uploaded, performed, and validated to be accurate on a mazor r<(>&<)>d station.Cages in the registration images indicate insertion of intra-disk implant prior to screw drilling.This process includes removal of spinal bony anatomy which increases mobility of the spine.L2 right and l3 left were both deviated superiorly as confirmed in post-op imaging.In addition, the fact that all other trajectories were accurate rules out platform shift and surgical arm inaccuracy.After reviewing all available information, analysis concluded the root cause for the reported deviation is skiving of the surgical tools on the boney anatomy.Planning the entry point at a tip of triangular bony anatomy increases risk of skiving, furthermore, insertion of cages prior to screw drilling increases spinal mobility and further increases risk of skiving on already high risk planned entry point, resulting in a superior than planned trajectory.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 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: 11623235
• MDR Text Key: 249453424
• Report Number: 3005075696-2021-00042
• 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,Followup,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• 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: 04/08/2021
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1