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); Pain (1994); Numbness (2415)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

Analysis of the software exports and logs found the complaint was confirmed.Analysis reviewed all available information and concluded the root cause of the inferior trajectory of right l2 was soft tissue pressure on the tools combined with the skiving potential in the planned trajectory.As for the last attempt sending the arm to right l2 trajectory resulting in a medial than planned trajectory, a patient or a platform shift cannot be ruled out as probable causes, as the patient was re-registered with pre-operation images after trajectories were executed, and the platform was not used according to surgical protocol.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 l3-l4 mini-open tlif with radiolucent retractors.The surgical system was mounted to the patient using a schanz pin placed in the right side of the patient connected to a bone mount bridge.All screws were accurate except for right l2.Left l2 was accurately placed.At right l2, the patient jumped during drilling.The right l2 trajectory was initially inferior by 3.5-10 mm when taking fluoro images.The surgeon went to right l3 and the trajectory looked off so they went to left l3 and l4 and placed accurate screws.Right l4 was then accurately placed.The surgeon went back to right l2 and removed the screw.Registration was redone.The registration segmentation lines were adjusted at l2 incase the lines were partially cut off.The surgical arm was sent to the trajectory and images were taken with the cannula, which was accurate.The screw was tested and came back at 5.An ap image was taken and the screw was medial even though navigation looked accurate.The screw skived between 3.5-10 mm.The surgeon decided to abort the use of the guidance system and place the right l2 screw freehand.The guidance system was used for the rest of the procedure.The surgeon and physician assistant controlled for soft tissue pressure.The clearance was noted to be tight, but the surgeon confirmed several times that the path was clear.The patient's physical exam showed right l2 nerve discrepancies, pain, weakness, and numbness.The patient was admitted to rehab and they made some progress, but they were still weak.The procedure was delayed less than an hour.

Manufacturer Narrative

D4: the serial number was updated.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; 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: 14929911
• MDR Text Key: 295324542
• Report Number: 3005075696-2022-00053
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109183213
• UDI-Public: 07290109183213
• 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: 09/01/2023

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: 06/23/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2020
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 130 KG