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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problems Unspecified Nervous System Problem (4426); Insufficient Information (4580)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

Analysis of the software export 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.High angles of the planning and the trajectory distance from the midline (> 3 cm), combined with long tools, can lead to soft tissue pressure applied on the surgical tools when instrumenting, resulting in medially deviated trajectories.The platform used was a schanz arm with a schanz screw to the r psis.Analysis reviewed the intra-op 3d scan and revealed schanz pin inserted only 1 cm into the bone.The insertion depth of the schanz pin could not provide an adequate platform stabilization, as it was not fully drilled into the boney anatomy.In addition, the selection of the 120mm schanz pin resulted in a larger work volume forcing the system to provide long tools solution.As reported the deviation could not be seen on the images.After the case, the patient experience right sided foot drop and changes in sensations.A dicom scan showed a breach of the canal in right l5 and right s1 screws.The log files show indication of excessive force applied on the surgical arm, halfway through the operation.Platform shift cannot be ruled out as the order of execution was l5 left, s1 left, l5 right, s1 right.An advanced accuracy test was conducted after the case, finding the surgical arm to be accurate, hence ruling out surgical arm inaccuracy as the root cause.After reviewing all available information, analysis found the root cause for the reported deviation could be one of, or a combination of, the following factors.Possible soft tissue pressure due to mid line surgical approach.Sub-optimal platform fixation with the selection of the 120mm schanz pin resulting in a larger work volume forcing the system to provide a long tools solution.When long tools solution is coupled with the extensive retraction, a large amount of force is applied on the bone coupler and bone mount.The schanz pin not fully drilled into the bony anatomy could lead to compromised platform stability.This may have resulted in a platform shift which led to the reported medial deviations as a consequence of the system being unable to withstand additional forces.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 l5-s1 case.A schanz pin was connected to a schanz arm to mount the surgical system to the patient.The surgeon began with left l5 and left s1 and a rod was inserted with no movement detected.Right l5 and s1 trajectories were completed next and a rod was placed.The manufacturer representative noted that the screw trajectories were altered during the procedure to accommodate soft tissue pressure.Ap and lateral images were taken and placement was approved by the surgeon.The deviation could not be seen on the images.After the case, the patient experience right sided foot drop and changes in sensations.The screws were removed later in the day due to being misplaced on the right side in the spinal canal.The screws were deviated by more than 10 mm.The patient experienced some recovery with forced eversion and some improvement in sensation.The representative suspected the deviation was caused by anatomy shift, platform mounting and soft tissue pressure.The procedure was delayed more than an hour.

Manufacturer Narrative

H3: a medtronic representative went to the site to test the equipment.Testing revealed no failures.The system then passed the system checkout and was found to be fully functional.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: 11378918
• MDR Text Key: 241006672
• Report Number: 3005075696-2021-00024
• 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
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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: 02/12/2021
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Weight: 75