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 Problem Nerve Damage (1979)

Event Date 10/31/2023

Event Type  Injury  

Manufacturer Narrative

A1 - a4: patient information was not available.H3, h6: a medtronic representative went to the site to perform a system check out and they found that the system functioned as intended.The system passed the bist, accuracy, and stress test.B01, c19, d14 are applicable to the system checkout.The logs/exports have been returned for clinical analysis.The analysis is still in progress.B21, c21, d15 are applicable to the clinical analysis.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that the l2 left was accurate.The site moved to l3 left and upon tapping the arm, the system stated it felt a force and was not on trajectory.The arm was moved away and the arm was resent to l3 left and the screw looked accurate, but it was not accurate.The screw was repositioned manually, but it appeared that the nerve root was damaged.All the other screws were accurate.The procedure was delayed less than one hour.

Event Description

Additional information received from a manufacturer representative reported that the trajectory was deviated by 3.5 - 10mm.

Manufacturer Narrative

A1, a2, a4: patient information was provided.See b5.H3, h6: the logs/exports were returned for clinical analysis.The analysis determined that the root cause of the left l3 screw deviation was the application of excessive force to the tools.This, combined with the inferior skiving potential in planning, led to the tools/screw slipping inferiorly along the cortical slope toward the l3/4 foramen.The risk of shifting the anatomy from its registered location due to the creation of excessive pressure on the anatomy or other undesired or unexpected damage is covered under risk-62664, dhf0477-01_0197.The risk of skiving surgical accessories is covered under risk-62215, dhf0504-01_0304.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 18212051
• MDR Text Key: 329041806
• Report Number: 3005075696-2023-00057
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109180465
• UDI-Public: 07290109180465
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203005
• 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: 12/07/2023

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: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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
• Patient Age: 76 YR
• Patient Weight: 103 KG