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

Model Number	TPL0059
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6) clinical data was received and is pending analysis.Codes b21, c21, and d16 are applicable.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 when doing a scan and plan, the first screw on the t12 left side was placed correctly, but the screws placed at l1 and l2 on the left side were medial by approximately 2 millimeters (mm).The right side screws were placed accurately.The screws at l1 and l2 left side were re-spun and re-placed; after replacing the screw at l2 left side, it remained medial by around 2mm.The screw was re-spun and re-placed a third time, and this placement was successful.No patient complications have been reported as a result of this event and surgical delay was one-hour or longer.
Additional Manufacturer Narrative
H2, b5: event details have been updated.H2, h3, h6: the system was serviced in the field.No failures were found.Codes b01, c19, and d14 are applicable.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 received from a manufacturer representative reported that they ran into trouble with wide the left l1 and l2 trajectory.The surgeon proceeded even though the representative felt the trajectory was wide.Both left l5 and l4 screws were not in pedicle, but lateral.The surgeon drilled, tapped and then inserted the screw.No bone removal was done prior to screw insertion.The surgeon was standing on the patient's left side when executing these screws.It was also noted that the patient had a swollen left buttock prior to and during the procedure.
Additional Manufacturer Narrative
H2, h3: clinical analysis was performed.It was determined that the probable root cause of the reported deviation was an anatomical instability.Previously reported codes b01, c19, and d14 are applicable.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 received from a manufacturer representative reported that prior to the procedure the patient had an l1 fracture on the right and was also affected by ankylosis spondylitis.
Additional Manufacturer Narrative
See 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.

• 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: 23994202
• Report Number: 3005075696-2026-00023
• Device Sequence Number: 13392743
• Product Code: OLO
• UDI-Device Identifier: 07290109184838
• UDI-Public: (01)07290109184838(11)211220
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K203005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/17/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 01/20/2026; 03/02/2026; 03/16/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/09/2026; 03/03/2026; 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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 Sex: Unknown