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

Model Number	TPL0059
Medical Device Problem Codes	Imprecision (1307); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa: 624392.H6: a medtronic representative went to the site to perform a system check out and they found the system functioned as intended.B01, c19, d14 are applicable to the system checkout.The exports/logs were returned for clinical analysis.The analysis determined that the root cause of the wrong level operation was mislabeling.The mislabeling happened due to the fact that thoracal vertebras have very similar features, and due to two misconceptions: 1.That the clamp was on t9 instead of t8, and 2.That fractured t10 was red due to the fracture.As these two landmarks should have supported the identification of the roi, misconception led to mislabeling and to wrong level operation.B01, c13, d11 are applicable to the clinical analysis.Multiple device codes are present.Below clarifies what each is associated with.A0803 - inaccuracy/medial screws a23 - screws implanted in incorrect vertebrae 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 the surgeon operated on the wrong level during an open procedure with a fractured t10 vertebrae.The plan was to fuse t8-l1 while skipping t10 due to the fracture.Two segments were planned since the anatomy was too long.The first segment used a region of interest from t7-t11 with mount placed at t9.The plan was to place screws at t8 and t9.Registration was completed and matched to what they thought was t8 and t9.T7-t9 had green values, t10 had red values due to the fracture and t11 had yellow registration values.The surgeon matched what they thought was t8 in the software and began inserting screws, but they were actually at t7.The surgeon did not realize the error until they moved to register the second segment.The level tested fine with neuromonitoring after the screws were implanted.The second segment had a region of interest from t11-l1 with a mount placed at t12.The plan was to place screws at t11-l1.A k-wire was placed at t11 and a 2d lateral shot was taken.The image showed that they were two vertebrae above t11 without screws.The surgeon confirmed t11 anatomically and noted that they had placed screws at t7-t8 instead of t8-t9 as intended.The right screws on t7 and t8 were shifted medially from the plan.The second segment was completed without issue.The surgeon then went back to t9, placed the mount, re-registered and placed the screw at that level.The fusion was extended by on vertebrae and included t7.There was no patient harm and the procedure was delayed less than hour.

• 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: 21304937
• Report Number: 3005075696-2025-00123
• Device Sequence Number: 8876537
• Product Code: OLO
• UDI-Device Identifier: 07290109181158
• UDI-Public: 07290109181158
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 02/04/2025

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: 02/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2018
• 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: 19 YR
• Patient Sex: Male
• Patient Weight: 72 KG