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

Model Number TPL0059

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Bone Fracture(s) (1870); Paralysis (1997); Unspecified Nervous System Problem (4426)

Event Date 03/15/2024

Event Type  Injury  

Manufacturer Narrative

H3, h6) software data was received for analysis and analysis confirmed the reported event.The results of analysis concluded that the root cause of the reported medial deviation of l5 right was soft-tissue pressure applied on the tools while instrumenting combined with skiving of the surgical tools medially on the boney anatomy.There were no software anomalies identified.Codes b01, c13, and d11 are applicable.H1) this type of report is considered both a serious injury and a malfunction.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 Description

Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that there was an alleged screw deviation in a scan and plan case.The manufacturer representative (rep) reported that the patient was having multiple screws placed from the thoracic to the lumbar vertebrae for a scoliosis procedure.The rep reported that multiple accuracy checks were performed, however, when t4 on the right side was drilled, the patient's motor was tested and was absent.When a post surgical scan was performed, the screw placed in t5 was potentially deviated by 1-2 millimeters (mm), but per the rep, the surgeon believed that the t4 drill was accurate and that the pedicle fractured on the right side.All other screws placed in the left and right vertebrae appeared accurate in the software.There was no surgical delay time and the patient was affected.

Event Description

Additional information received indicated that the patient woke with paralysis in the right leg, however, after 3 days the patient regained mobility and was expected to make a full recovery as per the attending surgeon.

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.

• Brand Name: MAZOR X SYSTEM
• Type of Device: 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19088649
• MDR Text Key: 339928332
• Report Number: 3005075696-2024-00046
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109184838
• UDI-Public: 07290109184838
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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
• Device Operator: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other