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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problems Muscle Weakness (1967); Nerve Damage (1979); Paralysis (1997); Discomfort (2330)

Event Date 07/28/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: a medtronic representative went to the site to test the equipment.Testing revealed that system was performing as intended.Clinical export data files were thoroughly inspected.The investigating team concluded that the probable cause for the deviations experienced in the operating room was due to a patient shift.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 there was a deviation during a single positioner lateral case from l2-l5.The surgical system was mounted to the patient using a schanz pin, schanz bridge and mis connector.The patient was noted to be small and was positioned with their left side up.The surgeon started at right l2 and placed the pedicle screws up before moving to the top side left and going down.During the case, the surgeon felt accurate and an intra-op x-ray was taken to confirm accuracy.When the surgeon drilled left l2, the patient had a bodily response and bucked, which did not seem to cause any issues and the case continued.The surgeon finished the left side, took an x-ray and proceeded with the olif portion.A day after the procedure, the patient had serious leg weakness and discomfort on their left side.A ct scan was done and l2-l3 on the left side were found to be deviated 3-5 mm medially and l2-l3 on the right side were 3-5 mm off laterally.The surgeon believed that the drill hit the nerve root when the patient bucked.The manufacturer representative noted that the evidence pointed to the patient rolling anterior in the bed after registration.The procedure was delayed less than an hour.Additional information was received stating that the next day when the inaccuracies were discovered the surgeon used the navigation system and imaging system to revise the patient and re-position the screws.The screws at l4-l5 were acceptable.Keep in mind this patient had significant coronal deformity with potential segmental instability so l2 and l3 could have moved independently.The equal translation of medial/lateral at l2 and l3 suggests the patient rolled anterior slightly.The bit got caught up in some soft tissue in the cannula and could have altered the path of the drill slightly.

Manufacturer Narrative

See b5.A1: patient initials were provided.H6: patient code added.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

Additional information received from a manufacturer representative reported that the patient became paralyzed during the surgery.

• Brand Name: MAZOR X SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IS 3079567
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IS 3079567
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15259355
• MDR Text Key: 298226626
• Report Number: 3005075696-2022-00059
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109184838
• UDI-Public: 07290109184838
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182077
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 59 KG