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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problem Pain (1994)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Analysis of the clinical exports and logs was completed.During the analysis, the clinical export data file was thoroughly inspected.The export file was generated by the mazor x system, and includes records of all the data that was used and generated by the system during the case, including but not limited to the intra-operative scans, preoperative planning, procedure actions that were executed, and the log text file.The log text file is a chronologic documentation of the software during operation, including trajectories sent by the system, star marker (sm) recognition accuracy, etc.The log file was examined with respect to all intraoperative fluoro images to inspect and understand procedure workflow.O-arm images were checked, star marker recognition was attempted with the registration, star marker images utilized during the operation on a mazor x r d workstation.Analysis reviewed the planning made for the case.A planning of l4-l5 tlif procedure was done for the specific segment.It seems that the trajectories planned in both l4 and l5 vertebras are very proud and placed in anatomical areas which have high chance of skiving potential.The nature of the deviation was reviewed.It was reported that during a t5-l4 tlif procedure, after placing the screws and doing a spin - l4 trajectories were thought to be slightly lateral and the patient experienced right side back pain.Observing the planning of l4 and l5 from axial views, it is shown that the planned trajectories are very proud (wide) and their location is sub optimal in an anatomical area with high potential for skiving.Analysis reviewed all available information and concluded the root cause of the deviations is sub-optimal planning, resulted in skiving potential for both l4 and l5 vertebras.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 were technical issues during a right left l4-l5 tlif procedure.The surgeon drilled pilot holes for all trajectories using a percutaneous technique.Screws were then placed.A post-op spin was done and the screws at l4 were found to be suboptimal and was slightly off by about 3.5 mm.The screws were slightly lateral and could have affected the rigidity of the construct.Troubleshooting during the initial procedure included checking landmarks.The patient experienced right side back pain.A revision procedure was done and the screws were reposition freehand.The suspected cause of the deviation was skiving and non-optimal entry planning.The procedure was delayed less than an hour.

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.

• Brand Name: MAZOR X STEALTH EDITION
• 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: 11453999
• MDR Text Key: 249709145
• Report Number: 3005075696-2021-00031
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• 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: 02/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• 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