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

Model Number TPL0059

Device Problem Imprecision (1307)

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

Event Date 10/11/2021

Event Type  malfunction  

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 there were deviations during a l4-s1 procedure.The surgical system was mounted to the patient using a schanz pin placed in the right psis connected to a bone mount bridge.Registration was then completed, followed by the surgeon doing a tlif with no issues.The patient was re-registered and the surgeon placed screws.Screws were placed starting at the top of the right side and working down and the moving to the left side working top down.Intra-op ct scans were done to confirm screw placement.The left side screws were medial by 0-3 mm and the right side screws were lateral 8-10 mm.The right screws were noted to have breached the vertebral body.Accuracy checks were completed throughout the case and navigation always appeared to be accurate.The surgeon had touched the instrument to the divot on the system and it was a little lateral.A new snapshot was taken and navigation looked good, but the surgical arm was inaccurate.A new registration was done, but the system was still inaccurate when the surgeon checked instrument placement with the c-arm.Navigation showed the instrument was accurate, but the instrument was off on the c-arm image.The surgeon switched to a scan & plan workflow and the same inaccuracy was found.The issue was occurring with all instruments used during the procedure.The surgeon decided to abort the use of the guidance system and reposition the screws freehand.After the procedure, the manufacturer representative completed an advanced accuracy test and the surgical arm passed.The representative noted that the surgical arm had passed a built in self test prior to the procedure.There was no patient harm and the procedure was delayed less than an hour.

Event Description

Additional information received from a manufacturer representative reported that the surgeon was located on the patient's left side and did not lean on the patient during the procedure.A patient shift was mentioned, but was ruled out as the issue was not resolved after re-registering the patient.

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.

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 the drill was used during the procedure and they did not believe a laminectomy was done prior to insertion of the screws.

Manufacturer Narrative

H3: a medtronic representative went to the site to test the equipment.Testing revealed that the system was working as intended and found to be fully functional.Analysis of the software exports 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.Fluoro images were checked and 3d registration was attempted with the registration 3d marker images utilized during the operation on a mazor x r<(>&<)>d workstation.Analysis reviewed the planning made for the case.No issues were found with the planned trajectories.Analysis reviewed the matching accuracy of the system.Three registration attempts were made: before cage insertion, after cage insertion and after l4-l5 right screws were found to be deviated.The ct-fluoro matching of the vertebrae were determined acceptable in all attempts.As reported, the left screws were medial 0-3mm, right screws were lateral 8-10mm.Right screws breached the vertebral body.Post op images attached confirm the reported deviation.As reported and seen from the images, the fixation platform used was a schanz pin with bone mount bridge.The bone mount was attached to the right psis.The deviation nature fits a platform or patient shift, which was already suspected in the or and therefore the correct troubleshooting of re-registering was taking place.However, placing the tlif cages before drilling seemed to have compromised the platform stability.Re-registering was the correct troubleshooting, but the screws kept falling into the previously drilled holes in each attempt.Analysis reviewed the log files provided.Log files reveal a change in s1 trajectory location, before and after cage insertion.Screw location of s1 shouldn't change due to the cages insertion, indicates changes in platform location as it is fixated in the same area.Indeed, s1 left coordinates changed right and inferior, as recorded by the system.Analysis reviewed all the available information and concluded the probable cause of the deviations to be an unstable platform.The insertion of tlif cages before drilling compromised the platform stability.As for the scan and plan, deviation persisted as the screws kept following originally drilled 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.

• 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: 12728046
• MDR Text Key: 279289071
• Report Number: 3005075696-2021-00118
• 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,Followup,Followup,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/01/2021
• Supplement Dates Manufacturer Received: 11/07/2021; 11/15/2021; 12/23/2021
• Supplement Dates FDA Received: 11/08/2021; 11/19/2021; 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2018
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 125 KG