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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/28/2022

Event Type  Injury  

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that during a revision surgery, the patient had misplaced thoracic screws.Original surgery of patient was on (b)(6), came in on (b)(6) and had revision surgery on (b)(6).There was no known impact on the patient outcome.The original surgery occurred on (b)(6) 2022, however the patient did not come back to the hospital until (b)(6) 2022 and had revision surgery on (b)(6) 2022.T11 to l3 burst fracture at l1.Surgeon was planning on placing screws from t11 to l3, including screws at l1 if it was possible.The case was done mis using solera 5.5/6.0 voyager.The residents made a small incision and placed the single amber clamp on the spinous process of l1.All the steps were taken to acquire the imaging system scan without issue.The manufacturer representative planned the screws as the surgeon watched and informed the rep where he wanted them placed.The patient had very small pedicles with some interesting anatomy.They noted a potential skive at t12 on the right.They started and the right and went top down.They sent each trajectory and the residents marked the skin.They moved the arm out of the way and cleared the extenders in the software while the resident made two incisions.The first from t11 to t12 and the second at l2 to l3.The arm was then sent back to t11.The resident inserted the outer cannula and dilator and advanced both down to skin level to check the accuracy.Once accuracy was verified the scalpel with the 22 blade was inserted and two incisions through the muscle were made.One in line with the spine and the second perpendicular to the spine.The dilator and outer cannula were inserted down to bone and then back up off bone.The midas was used to drill a pilot hole checking accuracy using navigation.It was accurate.The resident then tapped by hand watching navigation.The ats screw was then placed.The manufacturer representative was at the head of the bed watching the tooling and didn't notice any deviations.The steps were related for the rest of the screws on the right side.They then moved over to the left side.The resident was very heavy handed with placing the outer cannula and we checked accuracy.The navigation was off slightly so they did a snapshot and navigation was back to being accurate.They then did an anatomy check and the resident struggled to find an anatomical feature to check.The attending decided that the registration was off after checking a screw head.They went to the next segment in the software and obtained a new imaging system spin.While planning the screws on the new scan it was noted that t11 and t12 were lateral to plan but still in bone.L2 and l3 were further lateral with l3 being completely out of bone.After planning they went to the left and placed all the screws with caution.Then went back and replaced l2 and l3.The resident noted that he felt better this time at l2 and l3 than when he first placed the screws.After all the screws were placed, they did a third imaging system spin and determined that all the screws were accurate and in place.

Manufacturer Narrative

A medtronic representative went to the site to test the system.The system passed the system checkout and was found to be fully functional.A software analysis was initiated to determine the probable cause of the issue.Export and log files were reviewed.The investigating team concluded the root cause of the deviations experienced in the operating room was due to soft-tissue pressure applied on the tools while instrumenting, resulting in medially deviated t8-t10 trajectories.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 was received stating that patient symptoms included pain, as well as evidence of instability.Trajectories were deviated by 3.5-10mm.

Manufacturer Narrative

A1, patient identifier corrected.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: 15364577
• MDR Text Key: 299322192
• Report Number: 3005075696-2022-00064
• 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: 11/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 10/07/2022; 10/27/2023
• Supplement Dates FDA Received: 10/11/2022; 11/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female