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

Model Number TPL0059

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Discomfort (2330)

Event Date 08/24/2020

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.It was reported that a post-op scan showed that left l1-l3 screws were deviated laterally between 3.5-10 mm.During the implant procedure, a single schanz pin was used to mount the surgical system to the patient.The left side was done first and the right side was second.The thoracic screws on the right side were accurate.Intra-op imaging was done and the images looked good.The manufacturer representative thought there could be a shift that caused the deviation.The patient experienced some discomfort after the procedure and they were brought back in for a revision to reposition the screws on the following day.The procedure was delayed less than an hour.

Manufacturer Narrative

An analysis of software exports was completed.The clinical export data file was thoroughly inspected and the log file was examined in order to inspect and understand procedure workflow.The planning for the case was examined.It can be seen how the left side screws on l1-l3 were planned close to the facet.Positioning the screws this way may have created impact with the facet during instrumentation, throwing the tools off in the lateral direction.The registration attempts for the two segments were checked.No shifts were observed, and the attempts were deemed as accurate.The operated segment included t10-s2, which was executed in two parts.For all levels, the selected platform was a schanz screw in the psis.According to protocol for open procedures, it is recommended to use a schanz screw for l4-s2 levels only.Operating above l4 can lead to platform instability and may lead to deviations.The fact that only 3 screws have deviated out of the total 17 executed ones, eliminates inaccuracy of the device.The fact that the right side, which was accurate, was operated last, rules out any possibility of a platform shift.The deviations were confirmed.The way the screws were positioned matches the possibility of skiving laterally.After reviewing all available information, analysis concluded that the most probable cause for the lateral deviations at l1, l2 and l3 left, as experienced in the or, was skiving of the surgical tools.The deviated screws were planned near the facets, which probably caused the trajectories to skive.Even though a platform shift was ruled out as the cause for the deviations, it is important to mention that the platform used for this case was not according to protocol, as most trajectories were operated outside the operational range, meaning the upper levels (above l4) were not stabilized, which could have resulted in additional deviated 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 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
• MDR Report Key: 10553934
• MDR Text Key: 207542412
• Report Number: 3005075696-2020-00109
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• 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: 08/24/2020
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 70