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	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: a medtronic representative went to the site to test the equipment.They performed built-in self test (bist) testing, unit was mounted to the bed, stress test and accuracy performed both passed.No issues were found during the test and all values were within acceptable range.No hardware was replaced.Codes b01, c19, and d14 are applicable to this analysis.H3, h6: clinical analysis is pending.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 there was an alleged inaccuracy case during a posterior fusion l5-l1 perc case with perc pin.The manufacturing representative (rep) reported it was allegedly inaccurate by 5mm medial at l5 on the right from the plan.Rep reported the surgeon put in the medium pin and the pin seemed like it was not stable.Rep reported he then chose the long pin and made a comment about the thread pitch of the larger pin not being sufficient for the difference in the pins.The surgeon realized that the l5 was off when performing x-ray and chose to abort the system as he reported if one was off, he thought the whole structure was going to be off.The system was aborted and they proceeded using fluro, creating new pathways and free hand for the rest of the case.Rep reported this was a larger patient.There was less than an hour delay.Impact on patient outcome unknown.
Event or Problem Description
Additional information received from a manufacturer representative reported that no patient harm was reported.
Additional Manufacturer Narrative
The exports/logs were returned for clinical analysis.The analysis determined that the root cause of the reported deviation for l5 right and left was the skiving of surgical tools on the bony anatomy.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: 24304715
• Report Number: 3005075696-2026-00046
• Device Sequence Number: 17471507
• Product Code: OLO
• UDI-Device Identifier: 07290109184838
• UDI-Public: (01)07290109184838(11)210719
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/20/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• 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 Age: 36 YR
• Patient Sex: Female
• Patient Weight: 113 KG