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

Model Number	TPL0059
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Spinal deformity (4886)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that the patient underwent "pif" from levels t11-pelvis on 7/31.The patient was found to have proximal junctional kyphosis (pjk) and underwent surgery to reverse this.The patient was improving following index the surgery, but developed mid back pain along the proximal aspect of the thoracolumbar fusion, which was different from the patient's preoperative pain.The patient denied any lower extremity pain, paresthesia, or weakness, saddle paresthesia or bowel/bladder incontinence.On imaging, the patient was found to have a burst fracture of t11 vertebrae with pjk at t10-11.The patient then underwent a magnetic resonance imaging (mri) scan, medication refills, and subsequently an extension from their fusion from t4-t1.Thoracic kyphosis measured at 76 degrees, lumbar lordosis measured 59 degrees, pelvic incidence measured to the 70s, and pelvic tilt measured at 35 degrees.The bilateral posterior instrumented screw and rod fixation was present from t11 to the pelvis.The metallic interbody devices were present at l4-5, l5-6, l6-s1 with anterior plate fixation at l6-s1.There was pjk at the t10-11 level.Overall, these images were consistent with thoracolumbar fusion from t11 to the pelvis with pjk at t10-11.
Additional Manufacturer Narrative
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
D4, g3, h4: correction to serial number, 510k number, and manufacture date.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: 23686586
• Report Number: 3005075696-2025-00390
• Device Sequence Number: 9715495
• Product Code: OLO
• UDI-Device Identifier: 07290109184524
• UDI-Public: (01)07290109184524(11)200614
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K203005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2020
• 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: Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 101 KG