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	Dyskinesia (2363)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 2026-mar-18 (b)(4) (rep, hcp): medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that the workflow was ct to flouro with dot registration.L4 on the left was inserted first.However, when the surgeon moved to l5 on the left, he found that the bone was more difficult to drill and tap.After feeling that the tap was not advancing, the surgeon re-drilled and tapped again.It did not appear to be deviating at this time.The screw was inserted.The shots revealedthat l5 screw was lateral on the left.Around that time, the patient jumped with the drill still inside.The surgeon elected to switch to scan and plan.The imaging system scan revealed that right l4 was breached as a result of the patient jumping.For scan and plan, the surgeon did not dismount from the original mount, but still started from scratch.L5 on the left screw was inserted again.The surgeon then switched to the other side of the bed to work on l4.The guidance system arm stayed on the same side.The arm was sent to l4 and the screw was inserted.When the surgeon re-examined l5, he stated the screw felt weird, as if it wasn't in all the way.An x-ray was taken and it revealed that l5 on the left had shifted laterally.The result of the surgery was l5 shifting in both ct to flouro and scan and plan workflows, as well as a breach.There was less than an hour delay and no impact on patient outcome.
Additional Manufacturer Narrative
H3, h6: a medtronic representative went to the site to test the equipment.No hardware was replaced and the system performed as intended.Codes b01, c19, and d14 are applicable to this analysis.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.
Additional Manufacturer Narrative
B5 additional information.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 the they were not much over 3.5 millimeters (mm) inaccurate.

• 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: 24651329
• Report Number: 3005075696-2026-00073
• Device Sequence Number: 21334266
• Product Code: OLO
• UDI-Device Identifier: 07290109183213
• UDI-Public: (01)07290109183213(11)200316
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 04/06/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2020
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 100 KG