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	Cerebrospinal Fluid Leakage (1772); Insufficient Information (4580)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6) clinical 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
Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that during an l2-s1 open back procedure using the guidance system, an alleged inaccuracy of the guidance system occurred.The patient had previously undergone placement of four interbody cages at l2, l3, l4, and n5-1.On the day of the event, a computed tomography-to-fluoro imaging procedure was set up, and all required structures were confirmed to be in view.During the initial incision, only l3-s1 was exposed, and when the arm was sent to l2 on the left side, it was claimed that the arm had not navigated to l2.After retaking the image and exposing l2, the arm was sent to the left side of l2 again.While drilling for the guidance system, the patient's leg exhibited involuntary movement ("jumped"), prompting the surgeon to stop and switch to tapping.The patient's leg jumped again during tapping, a nd cervical spinal fluid was observed.The use of the guidance system was aborted for the remainder of the procedure, and the surgeon continued using medtronic imaging and navigation.It was noted there was there was no impact to patient's outcome.
Additional Manufacturer Narrative
H6 additional information.A150204 - arm did not reach location.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 there were no symptoms associated with the reported incident and there were no deviated projections during the procedure.
Additional Manufacturer Narrative
Correction: continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id:asm0206, serial number: unknown.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 surgeon did not expose the proximal lumbar anatomy (l2).When the manufacturing representative (rep) sent the arm to the l2 trajectory, the surgeon thought she exposed l2 when in fact she exposed up to l3.So, she said the trajectory was off.They then took an ap shot with the imaging system to verify the exposed lumbar anatomy.After verification, the surgeon realized that she did not expose l2 and that the trajectory was correct.Once the arm was sent to the l2 trajectory after re exposing the correct anatomy (l2), the cannula was passed down the arm guide and the trajectory imaging showed no deviation.The surgeon then placed the drill for the guidance system down the guide and again there were no deviations.The surgeon then passed the drill.After drilling with the drill for the guidance system, the surgeon then passed the tap and again there were no deviations.The rep stated that after looking back through his report, there was not an initial report that there was clear inaccuracy.
Additional Manufacturer Narrative
D4 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.
Additional Manufacturer Narrative
H3, h6: the exports were returned for clinical analysis.The analysis determined that the probable causes of the reported issues were soft-tissue pressure due to an insufficient incision, as well as a potential encoder issue at joint 4.Codes b01, c07, and d02 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: 24149604
• Report Number: 3005075696-2026-00030
• Device Sequence Number: 8859467
• Product Code: OLO
• UDI-Device Identifier: 07290115751376
• UDI-Public: (01)07290115751376(11)230514
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K230064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/14/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/22/2026; 02/16/2026; 02/16/2026; 02/20/2026; 04/08/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/16/2026; 02/20/2026; 02/20/2026; 03/02/2026; 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 80 KG