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

Model Number	TPL0059
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a guidance system being used outside of a procedure.It was reported that defect-24497 was identified.To reproduce the user must proceed to the operation screen and choose towers on, send the arm to a screw in order to create a tower, choose the tower in the towers tab (tower color is red), and enter edit work volume(wv).The actual result was that the tower color was red in the "edit wv" screen, which is the wrong behavior.There was no patient involvement.Additional information received indicated the problem occurred on software version 5.1.1.30.
Additional Manufacturer Narrative
H7) this regulatory report is being submitted due to retrospective review through fa1523, 806 report # 3005075696-12/16/2025-001-c.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: kit1378-05, software version: 5.1.1.30 h3, h6) analysis was performed for this event.In summary, a software defect was confirmed.Codes b01, c10, and d18 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.

• 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: 23939590
• Report Number: 3005075696-2026-00005
• Device Sequence Number: 18381326
• Product Code: OLO
• UDI-Device Identifier: 07290109183213
• UDI-Public: (01)07290109183213(11)200101
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K230064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/01/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 01/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2020
• 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 Sex: Unknown