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

Model Number	TPL0059
Medical Device Problem Codes	Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A05: bist would fail a0908: inaccuracy, off the divot d10: product id: asm0206-04r, serial #: (b)(6), ubd: unknown, udi#: unknown f1906: robot was aborted f1908: delay to the procedure of 20-30 minutes f26: no patient impact g07002: surgical arm h3, h6: the system was serviced in the field.The arm was replaced, and a system checkout was completed.The system was ready for use.Codes b01, c07, and d02 are applicable.H3, h6: the surgical arm has been returned for analysis but is pending analysis completion.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 an alleged inaccuracy occurred during a l3-l5 case.All screws were all shifted bilaterally to the right.It was additionally reported that when performing the built-in self-test (bist) at the beginning of the case, the bist would fail and the system had to be rebooted to perform the bist again and successfully pass.When noticing the inaccuracy after spin, the surgeon initially thought it was a navigational shift as anatomy looked to be good, but when performing the turkey foot arm test, it looked to be a little off the divot but very close to divot.The robot was aborted from the case and the case proceeded using navigation.After the case, the advanced accuracy test was performed and one was running against the wall.There was no impact to patient's outcome.There was a delay to the procedure of approximately 20-30 minutes.The amount of inaccuracy was less than 3.5mm, closer to 2mm.
Additional Manufacturer Narrative
H3, h6: the surgical arm, lot number: sra0042, was returned to the manufacturer for analysis.The arm was found to have failures such as a mechanical part failure, broken plastic cover, kaydon bearing failure, harmonic drive failure, faulty plastic gear, worn or torn rubber o-ring, damaged screws, faulty bottom plate, faulty body, accuracy test failure, and an encoder failure.Codes b01, c07, and d02 are applicable to this analysis.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: 24223412
• Report Number: 3005075696-2026-00041
• Device Sequence Number: 8326221
• Product Code: OLO
• UDI-Device Identifier: 07290109180465
• UDI-Public: (01)07290109180465(11)171105
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K230064
• 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,Followup
• Report Date (Section B): 04/20/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 04/19/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 77 KG