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

Model Number	TPL0059
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
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 the surgeon attempted an l4-5 perc fusion.The surgeon did a direct lateral approach with a titan titanium cage and flipped the patient to utilize the guidance system for perc screws started at l3-4 screws first then moved to the other side.All screws were placed and then using c- arm to acquire confirmation shots, it appeared both l3 and l4 were placed laterally on the right side by ~5mm.Left screws were accurate.During the verification portion of registration they did have an image shift which required them to take new images.Once new images were acquired, the site then got a "yellow" value at l4.They paid extra attention to make sure there was not a shift.The site then proceeded.They aborted use of the guidance system and replaced the deviated screws manually.The issue extended the surgical time by less than 1 hour.There was no known impact on the patient outcome.Additional information received from a manufacturer representative reported that another case was successfully completed and they believed the deviation was due to a patient shift.There was not a patient shift originally.When verifying that the ct and fluoro shot were superimposed the site noticed a shift in the images.The site retook the images.They used a shanz pin with the shanz bond and bone mount bridge.
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.A1: patient initials was unavailable.H3, h6: the exports/logs were returned for clinical analysis.The analysis determined that the most probable cause for the deviations experienced in the or is platform or patient shift that happened after left side screws were executed.The fact that the trajectories deviated to the same direction and by the same amount, further highlights a shift as the cause.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: 21403673
• Report Number: 3005075696-2025-00196
• Device Sequence Number: 8235450
• Product Code: OLO
• UDI-Device Identifier: 07290109181158
• UDI-Public: 07290109181158
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K182077
• 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
• Report Date (Section B): 02/18/2025

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
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2018
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 77 KG