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

Model Number	TPL0059
Medical Device Problem Codes	Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: mas2330 h3, h6: no parts were returned for product analysis.Multiple device codes were applied.Below clarifies what each is associated with.A05 - arm guide wobbly a0908 - inaccuracy a23 - registration issues medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that site proceeded using a ct to flouro workflow.The manufacturer representative obtained good images from the c-arm, but ultimately could not get the robot to register.The representative took new c-arm images, but the issue persisted.The surgeon and representative decided to switch to a scan and plan.A spin was taken, and screws were planned without issue.However, when the arm was sent to the first trajectory, it became clear that navigation was off by several millimeters.The representative confirmed this by taking another c-arm image.At this point, the representative noticed that the arm guide was wiggling excessively.The representative retightened the arm guide, and took another spin.However, this spin did not have matching patient id's, so it could not be used.The representative switched back to ct to flouro, and the new set of images produced by the c-arm resulted in the patient getting registered without issue.There was no patient harm and the procedure was delayed one hour or longer.Additional information was received.It was reported that it was believed the issue to be a workflow issue and that the arm guide was not securely tightened.
Additional Manufacturer Narrative
H2) additional information in section b5.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received.It was reported that trajectories were deviated greater than 10 millimeters (mm).

• Brand Name: MAZOR X SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 1 haeshel street. (building c); caesarea business park; caesarea hefa,il 30798 30; IS 3079830
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 1 haeshel street. (building c); caesarea business park; caesarea hefa,il 30798 30; IS 3079830
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21918669
• Report Number: 3005075696-2025-00258
• Device Sequence Number: 9096467
• Product Code: OLO
• UDI-Device Identifier: 07290109181158
• UDI-Public: 07290109181158
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K230064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 73 KG