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

Model Number TPL0059

Device Problems Imprecision (1307); Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/03/2021

Event Type  malfunction  

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that there was a deviation during the procedure.Ct-fluoro workflow was used and a clamp was placed at l1 and t11.Registration for t8 to l3 was done and the surgeon placed screws on the left side first.The surgeon then moved to the right side and placed screws starting at l3.For the second segment, the clamp was moved to t4 and t6.During registration of t3-t7, red values were obtained for t3.The manufacturer representative manually adjusted the registration and got yellow values.The surgeon confirmed that nothing had moved.When drilling left and right t3, the surgeon breached the canal and saw some blood flow.The same thing occurred at left t4.Accuracy was checked during the procedures on the spinous process.The trajectories were deviated between 3.5-10 mm.Suction and cauterization was used to resolve the blood flow.The representative noted that there was soft tissue pressure and retraction, but not enough to cause the deviation besides t3.The use of the guidance system was aborted and the surgeon freehanded the screws.There was no patient harm and the patient's motor function was fine after the procedure.The procedure was delayed less than an hour.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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 case was open with t3 at the apex.A bone mount bridge connected to a dual clamp was used to mount the surgical system to the patient.The representative did not think there was soft tissue pressure.If there were skive potentials at trajectories, the surgeon used a rongeur to bit down.

Manufacturer Narrative

H3: analysis of the software export and logs was completed and analysis confirmed the complaint.Clinical export data file was thoroughly inspected.The log file was examined with respect to all intraoperative fluoro images in order to inspect and understand procedure workflow.Analysis reviewed the planning made for the case.T3 and t4 were planned with high axial angles (>12 deg).In l3 right inferior and a possible medial skiving was detected.Analysis reproduced registration results.For l3 and t4 the ct-fluoro match score shows acceptable values, though slight shifts were detected.For t3 it was reported that "red values were obtained for t3.The representative manually adjusted the registration and got yellow values.The surgeon confirmed that nothing had moved." registration results indeed yielded yellow values with difficult detection of anatomic landmarks in fluoro images.As reported, "when drilling left and right t3, the surgeon breached the canal and saw some blood flow.The same thing occurred at left t4." post-op images provided confirm the breach of left t4.For t3 it seems the post-op was taken after re-adjustment of the screws.No post-op images were provided for the lower segment which included l3.T3, t4 and l3 has all deviated medially, and adjacent to the skin incision edge, hence prone to soft-tissue pressure, pushing the tools medially while drilling.No evidence of platform shift were noticed - and the log files show no indication of excessive force applied on the surgical arm; moreover, the fact that the trajectories executed before and after the deviated ones were accurate, a platform shift can be ruled out.After eliminating patient or platform shift, analysis reviewed all the available information and concluded the probable cause of the deviation of t3 bilateral, left t4 and possibly right l3 is soft-tissue pressure applied on the tools while instrumenting, or retraction, resulted in medially deviated trajectories.Medial deviations in trajectories adjacent the edge of the incision are very likely to be due to soft tissue pressure or retraction.Soft tissue pressure in combination with the drill can easily push the drilling trajectory 1-2 mm and when inserting the screw it can be pressed with the canal walls even more medial.Retraction can lead to spine mobility, pulling the vertebra and lead to medial or angled entry point.A registration shift may have served as a contributing factor to the deviations.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: 12844444
• MDR Text Key: 281518270
• Report Number: 3005075696-2021-00126
• 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,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• 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: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2019
• 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 Age: 24 YR
• Patient Sex: Female
• Patient Weight: 54 KG