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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problems Muscle Weakness (1967); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2020

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 to treat trauma with fixation.It was reported that one of the screws placed using the guidance system was medial and the other screw was lateral.Both screws were deviated between 3.5-4.5 mm.The manufacturer representative noted that the patient had a fractured spine and the likely cause of the deviations was a shift in the spine during placement.The deviations were found during imaging with the c-arm after the procedure.The patient had a revision to reposition the screw on (b)(6) 2021. during the revision, right l4 deviated medially due to the screw following the old trajectory.The trajectory was resent and the screw was able to be accurately placed.The representative noted that the surgeon like to complete everything at each level before sending the surgical arm to the next trajectory.The procedure was delayed less than an hour.

Manufacturer Narrative

H3: a medtronic representative went to the site to test the equipment.Testing revealed there were no failures found.The system then passed the system checkout and was found to be fully functional.Analysis of the exports and logs 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 x r & d workstation.Analysis reviewed the planning of the reported deviated trajectories.In both l4 and l3 r, we can see sub-optimal planning.The landing site of the drill guide was partial which could induce deviations in the trajectory.Also, the drill entry point was not engaging the bone surface and could deviate in the path of least resistance (l3 inferior and l4 medial/ inferior).Analysis reviewed the log files of the registration.The registration done in the or was recreated at the labs and all vertebras received green with similar values.All through the deviation nature was not reported.From the lateral view of the x-rays submitted, the right l3 exhibits an inferior trajectory in relation to the planning and the right l4 exhibits good inferior/ superior alignment to the planned trajectory.After reviewing all available information, analysis concluded that the registration process was acceptable and within the matching values.Suboptimal planning can induce l3 right inferior skiving and l4 right medial skive.The chosen platform was a schanz pin in the psis which for an open case is designated up to l4.The correct platform taking into consideration the fracture l2 which increases spinal mobility is a clamp.The combination of suboptimal planning, wrong choice of a fixation platform, and spinal mobility due to l2 fractured vertebra are most likely to induce the reported deviation.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 multiple accurate cases have been completed since the event.The representative had made suggestions about the surgeons technique, the possibility of the spine "torquing" with instrumentation and using the clamp versus pelvic fixation, but the surgeon disagreed with these as the cause of the deviations.

• 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: 11197919
• MDR Text Key: 227742813
• Report Number: 3005075696-2021-00010
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109180465
• UDI-Public: 07290109180465
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: 12/27/2020
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR