MAUDE Adverse Event Report: MAZOR ROBOTICS LTD MAZOR RENAISSANCE SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number TPL0038

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2020

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 there were deviations during the procedure.The first and third screws placed were too lateral.The cause of the deviation and the amount of deviation was unknown.The second and fourth screws placed were accurate.The deviations were recognized in the post-op ct scan.A revision was done on the same day to manually replace the screws.There was no patient harm and the procedure was delayed more than an hour.

Manufacturer Narrative

Software analysis 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.Fluoroscopic images were checked and 3d registration was attempted with the registration 3d marker images utilized during the operation on a renaissance workstation.Analysis reviewed the planning of the trajectories.In all the trajectories the screws midline which represents the drill pathway is planned through the facets.Though this did not cause the reported deviation it is recommended to avoid planning through the facet as it can lead the drill to deviate from planning.The platform chosen was a disposable clamp.The clamp was positioned between two spinal processes, which can impair the platform stability.Nevertheless, seven teeth were engaged with the spinal process bone.Together with the additional headpin, analysis concluded that the fixation was adequate.The position of the drill guide was far back from the body and pedicle, probably not engaging the bone adequately.This is also supported when examining the position of the implant to the planning.When examining the lateral validation image, it can be seen that the left and right implants are not leveled.This suggests a different drill guide positioning (depth).Right l4 and right l5 were lateral to the pedicles.From the data received, the platform was correctly assembled.The registration was redone and found to be accurate.The difference between left and right trajectories in conjunction with a zig-zag surgery suggests rbt accuracy that was also validated in the log files.The deviations were most likely as a result of poor surgical technique on the right side.More specifically, drill guide positioning, which did not engage the bone properly.This was also supported by the depth of the right-side implants.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 RENAISSANCE SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67
• MDR Report Key: 10135388
• MDR Text Key: 194603175
• Report Number: 3005075696-2020-00093
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K152041
• 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: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Date Manufacturer Received: 06/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR