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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problem Pain (1994)

Event Date 11/04/2021

Event Type  Injury  

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that the patient had severe pain two days after a l5-s1 tlif procure was completed.Imaging was done and the right l5 screw was deviated by 1-2 mm inferior.During the procedure, a schanz pin was placed in the right psis to mount the surgical system to the patient.A mis ct-fluoro workflow was followed.High skive potential was noted on the trajectories.The surgeon started completed the screws in the following order: left l5, left s1, right l5 and right s1.When drilling l5, the surgeon had to use excessive force to drill due to hard bone and difficulty breaking through the posterior wall.When working on left l5, the surgeon had to re-adjust during the procedure.The manufacturer representative believed the high inferior skive potential and difficulty drilling the bone contributed to the deviation.The procedure was delayed less than an hour.A revision procedure was done to remove both screws at l5.The surgeon decided not to placed screws at that position.The patient was doing well after the revision.

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

H3: analysis of the software exports and logs found the complaint was confirmed.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.Fluoro images were checked and 3d registration was attempted with the registration 3d marker images utilized during the operation on a mazor x r workstation.Analysis reviewed the planning of the case.It can be seen that significant inferior skiving potential can be noticed on l5 right.The registration was uploaded, performed, and validated to be accurate.According to the clinical representative that attended the case:" high skive potential was noted on the trajectories." the l5 right trajectory was confirmed deviated while taking image: ¿imaging was done and the right l5 screw was deviated inferior¿ indeed, l5 left was confirmed to be inferior, confirmation images attached show inferior deviation in l5 right.Furthermore, according to clinical representative that attended the case: "when drilling l5, the surgeon had to use excessive force to drill due to hard bone and difficulty breaking through the posterior wall." however, the log files show no indication of excessive force applied on the surgical arm.Additionally, the patient had severe pain two days after the procedure was completed.A revision procedure was done to remove both screws at l5.The patient was doing well after the revision.After reviewing all available information, analysis concluded the root cause for the reported deviation is skiving of the surgical tools on the boney anatomy.Sub optimal planning may have been a contributing factor resulting in an inferior than planned trajectory.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: 12771070
• MDR Text Key: 280464298
• Report Number: 3005075696-2021-00123
• 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: 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: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• 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: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 100 KG