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

Model Number	TPL0059
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Advance (2524)
Health Effect - Clinical Codes	Paralysis (1997); Perforation (2001)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: asm0206, serial: unk a1-a4: patient information was not available.H3, h6: the exports/logs were returned for clinical analysis.The analysis is still in progress.Multiple device codes and patient codes were applied.Below clarifies what each is associated with.A0908 - inaccuracy a150204 - arm not reaching the snap shot position e012202 - paralysis e2114 - penetrated spinal cord 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 while performing a percutaneous voyager spine case with ct to fluoro and controlling the screw placements with x-ray, the surgeon noticed that the screws were placed wrong.One of the holes drilled was located too medial and the spinal cord was penetrated leading to paralysis of the patient.It was also noted that the nurse intended to perform a snapshot, but the arm could not reach the snap shot position, because the percutaneous extenders of the voyager system logged in the system prevented the arm from reaching snapshot position.The manufacturer representative advised the site to delete the voyager extenders from the software, so that the robot could lower itself into the snapshot position.The site was then able to perform a snapshot and then performed the navigation accuracy testing and thereafter the anatomy accuracy testing.Navigation was accurate, but the representative suspected the anatomy was not.The representative advised them to redo the ct to fluoro registration.The procedure was delayed less than 1 hour.
Event or Problem Description
Additional information was received.It was reported that the screws were removed after the faulty position was seen intra-operatively and were not seen on post-operative three-dimensional (3d) scans.The amount of deviation was estimated to be 10-15mm.
Additional Manufacturer Narrative
H2, b5: event details have been updated.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
Concomitant product asm0206 serial #: (b)(6).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: 24474793
• Report Number: 3005075696-2026-00065
• Device Sequence Number: 13172779
• Product Code: OLO
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Date Returned to Manufacturer: 02/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 03/20/2026; 03/26/2026; 04/20/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/25/2026; 03/31/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown