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	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that during a transforaminal lumbar interbody fusion (tlif) surgical procedure, the navigation instruments were off-plan.The difference between the original trajectory and the live instrument was noticeable, and the navigation picture appeared different from the carm plate.A snapshot was performed, and the instruments were registered again, but the same problems persisted.No patient complications have been reported as a result of this event and there was no surgical delay time.Additional information was received.It was reported that the surgical arm was replaced proactively and there were no software issues encountered during the replacement.
Additional Manufacturer Narrative
H3, h6: the system was serviced in the field.In summary, the issue was unable to be replicated and no software issues were encountered.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.
Additional Manufacturer Narrative
H2) additional information in section b5.H3, h6) software 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
Additional information was received.It was reported that the procedure wasn¿t aborted due to this issue.The arm accuracy was confirmed using a non-medtronic imaging system and it was presided.The event of instruments being off plan was unable to be resolved during the procedure.
Additional Manufacturer Narrative
H3, h6) a clinical analysis was conducted.In summary, a thorough investigation could not be conducted due to the lack of the export file.Previously reported codes, b01 and c19 are applicable, as well as newly reported code, d15.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: 22142770
• Report Number: 3005075696-2025-00271
• Device Sequence Number: 7356175
• Product Code: OLO
• UDI-Device Identifier: 07290109181158
• UDI-Public: (01)07290109181158(11)180315
• Combination Product (Y/N): N
• PMA/510(K) Number: K182077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 06/26/2025; 07/28/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/15/2025; 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2018
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 78 KG