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

Model Number TPL0059

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Nerve Damage (1979); Pain (1994); Perforation (2001); Burning Sensation (2146); Unspecified Nervous System Problem (4426)

Event Date 11/15/2023

Event Type  Injury  

Manufacturer Narrative

A.1-a.5) patient information was included in the journal.A.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.A.4.The patient's weight was no provided.B.3.Please note that this date is based off of the date the article was published online as the event dates were not provided in the published literature.B5 included the article citation d.4.The system serial number was not provided in the journal article.H.3.No evaluation was performed as the event was reported as a literature article.H.4.Device manufacturing date was unavailable.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.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

Farivar, d., kim, t.T., sy, c.A., baron, e.M., nomoto, e.K., walker, c.T., & amp; skaggs, d.L.(2023).Complications have not improved with newer generation robots.Global spine journal.Https://doi.Org/10.1177/21925682231216081 objective: the purpose of this study was to see whether upgrades in newer generation robots improve safety and clinical outcomes following spine surgery.Methods: all patients undergoing robotic-assisted spine surgery with the mazor x stealth editiontm (medtronic, minneapolis, mn) from 2019 to 2022 at a combined orthopedic and neurosurgical spine service were retrospectively reviewed.Robot related complications were recorded.Results: 264 consecutive patients (54.1% female; age at time of surgery 63.5 ± 15.3 years) operated on by 14 surgeons were analyzed.The average number of instrumented levels with robotics was 4.2 ± 2.7, while the average number of instrumented screws with robotics was 8.3 ± 5.3.There was a nearly 50/50 split between an open and minimally invasive approach.Six patients (2.2%) had robot related complications.Three patients had temporary nerve root injuries from misplaced screws that required reoperation, one patient had a permanent motor deficit from the tap damaging the l1 and l2 nerve roots, one patient had a durotomy from a misplaced screw that required laminectomy and intra-operative repair, and one patient had a temporary sensory l5 nerve root injury from a drill.Half of these complications (3/6) were due to a reference frame error.In total, four patients (1.5%) required reoperation to fix 10 misplaced screws.Conclusion: despite newer generation robots, robot related complications are not decreasing.As half the robot related complications result from reference frame errors, this is an opportunity for improvement.Two hundred and sixty four patients underwent spinal surgery to address various spinal issues.There were complications with six patients.There were three occurrences of nerve root injury from misplaced screws requiring reoperation and back pain.There were two occurrences of sensory deficit and motor deficit.There was one occurrence of a nerve root injury from the tap requiring reoperation, durotomy from misplaced screws requiring intra-operative repair, and nerve root injury from drilling.There were ten misplaced screws, suspected to be due to reference frame errors.This was likely a technical error on the part of the surgeon, resulting in the reference frame unintentionally moving.Some individual patient experiences were provided.A seventy six year old male had a medial breach at right t10 and a screw that was lateral at left t10.There was also a medial breach at right t11 and lateral screw on left t11.The patient presented with worsening back pain.Both screws were shifted by ten millimeters.The surgeon believed that the reference frame was placed too far from the t10/t11, which resulted in movement over time.A seventy one year old female also had a medial breach at left l1 and a screw that was lateral at right l1.The patient presented with back pain and new weakness of the right quadriceps and iliopsoas muscles.Both screws were shifted by ten millimeters.The surgeon also believes this was reference frame issue.The patient later required reoperation for screw removal.A seventy year old male had a medial breach of left l4.The patient then presented with numbness and weakness in the left lower extremity.The attending surgeon believed there was soft tissue pushing against the cannula.The patient later needed reoperation to remove the screw.A seventy six year old female had a lateral screw placed in left l2, l3, and l4, and a superior screw intended for left l5, but was placed in the l4-l5 disc space.The patient presented with new back and left lower extremity pain.The patient later required reoperation to replace the screw.Finally, a patient with grade iv spondylolisthesis had a transdiscal screw placed in l5 that pushed away relative to the reference frame , which resulted in the drilling hitting the nerve root.This resulted in an immediate spine in the patient's emgs, their leg kicking, and they proceed to have three months of a burning sensation on their dorsal foot.

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.

• Brand Name: MAZOR X SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 1 haeshel street. (building c); caesarea business park; caesarea hefa,il 30798 30; IS 3079830
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 1 haeshel street. (building c); caesarea business park; caesarea hefa,il 30798 30; IS 3079830
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18319254
• MDR Text Key: 330428632
• Report Number: 3005075696-2023-00061
• Device Sequence Number: 1
• Product Code: OLO
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Disability; Required Intervention; Other
• Patient Age: 64 YR
• Patient Sex: Female