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

Model Number	TPL0038
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that there was a inferior sacral deviation at s1 during a l5-s1 case.The rbt device was remounted to the patient and registration was done again, but the issue was not resolved.The cause of the deviation was not determined.The rbt device passed an advanced accuracy test.There was no patient harm and the procedure was delayed less than an hour.
Event or Problem Description
Additional information received from a manufacturer representative reported that troubleshooting involved re-registering the patient, remounting the surgical system and checking for shifts.The trajectories were deviated between 3-5 mm.The case was completed and the surgeon decided to leave the screws implanted.
Additional 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.
Additional Manufacturer Narrative
H3: analysis of the software exports and logs found the complaint was confirmed.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.Analysis reviewed the planning of the case.S1 trajectories were planned at a point which had no docking on the bone facet.Analysis recreated the registration results achieved in the operating room and found them acceptable with no observable shifts.Images provided in the export file show the cannula to be docking correctly as planned, but when instrumenting the drill guide it seems to be docking inferiorly, indicating surgical technique and/or unstable anatomy.Due to planning, cannula might have not reached the bony anatomy, showing the robot location to be as planned.When the drill guide reached the bony anatomy the trajectory changed- this may be a cause for anatomy shift.By examining the images of the registration, it can be seen that laminectomy was done, enabling the vertebra to be pushed down while instrumenting.In addition, as reported, re-registration didn't solve the problem and the rbt device passed an ad vanced accuracy test afterwards.This rules out platform shift and rbt device inaccuracy.After ruling out, registration shift, surgical arm accuracy platform or patient shift as the cause of the reported inaccuracy, analysis concluded the deviations reported were due to anatomy shift, resulting in discrepancy between the tools and the position of the anatomy of the s1 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: RENAISSANCE SYSTEM
• Common Device Name: NEUROLOGICAL 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: 11935843
• Report Number: 3005075696-2021-00067
• Device Sequence Number: 11537838
• Product Code: HAW
• UDI-Device Identifier: 07290109180267
• UDI-Public: 07290109180267
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K152041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/03/2021; 10/18/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/24/2021; 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 60