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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problem Insufficient Information (4580)

Event Date 04/21/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: asm0206, serial/lot #: (b)(4), udi#: (b)(4).A medtronic representative went to the site to test the equipment.Testing revealed that surgical arm pass and accuracy, navigation and built in self test, but failed the stress test at j5.A field motor calibration of the surgical arm was done and the arm then passed all testing.The system then passed the system checkout and was found to be fully functional.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 was a deviation during a l3-l5 spinal fusion case.Ct-fluoro registration and 3define scan were completed without issue.An accuracy check on the arm guide passed.After successful setup, the surgical arm was sent to left l3.The surgeon placed the screw and the neuromonitoring dipped during placement.The screw was removed and the surgeon used a pedicle finder to determine the location.After checking the hole location, the placed the screw and neuromonitoring was triggered again.The surgeon removed the screw and checked the hole with a pedicle finder again.The surgeon determined there was a lateral breach.The screw was placed manually without the surgical arm.The surgeon decided to restart the setup and registration process with the guidance system.Setup was completed without issue using two new flouro images.The surgical arm was sent to left l4 and an accuracy check was done.The surgical arm failed the accuracy check so the surgeon decided to abort the use of the guidance system and complete the procedure using navigation.The procedure was delayed over an hour.

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.

Event Description

Trajectories were deviated less than 3.5mm and no patient harm was done.

• Brand Name: MAZOR X SYSTEM
• 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
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IS 3079567
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14245808
• MDR Text Key: 290451311
• Report Number: 3005075696-2022-00041
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109184838
• UDI-Public: 07290109184838
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 73 KG