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

Model Number TPL0059

Device Problems Imprecision (1307); Connection Problem (2900)

Patient Problems Cerebrospinal Fluid Leakage (1772); Urinary Retention (2119); Unspecified Nervous System Problem (4426)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed no failures.The system then passed the system checkout and was found to be fully functional.Analysis results for the software exports 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.

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that the ct scan was not uploading to the guidance system so a scan <(>&<)> plan procedure was done.During the procedure, the surgeon placed screws in the following order: right l3, right l4, left l3 and left l4.The surgeon then proceeded to place sextant wires.The surgical arm was sent to the trajectory for the disk space between l3/l4.The surgeon drilled, tapped, placed a wire and then moved the surgical arm to the clear right position.The surgeon dilated over the wire, placed a 12 mm tube and connected to a bionic arm retractor.The manufacture representative noted that the bionic arm retractor wasn't working properly and needed an hour to adjust the retractor several times.The surgeon used a 9 mm acorn midas bit placed through the 12 mm tube and surgical arm.Drilling was watched using fluoro.Shots were taken throughout and all wires were clear and within the pedicle.The surgeon then implanted a flare hawk cage, followed by screws.The surgeon indicated that there was a dural tear that had to be repaired.Several post-op cts were done and the surgeon confirmed the screws looked good.The representative noted that the surgeon did not mallet the drill guide, which could have i increase the skive potential.The representative noted that the wire at right l4 was removed too early and the screw may have be a bit lateral.Several days after the case, the patient experienced bi-lateral foot drop.The surgeon thought the symptoms were caused by a "glitch" of the guidance system and a scan <(>&<)> plan procedure was not as accurate as ct to fluoro procedures.A revision procedure was done to repair the dural tear and remove hardware from the patient's right side that was deviated less than 3.5 mm.The procedure was delayed over an hour.

Manufacturer Narrative

H3: analysis of the software exports was completed and the complaint was confirmed.H3: 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.There was a lateral skiving potential in l4 right trajectory.As reported, skiving was due to removal of the wires too early and possibly because the surgeon did not mallet the drill guide which has been noted to increase the potential to skive.Analysis reviewed the images provided.A lateral deviation can be seen in l4 right.The log files show no indication of excessive force applied on the surgical arm, and platform shift can be ruled out as the subsequent trajectories were accurate.After ruling out arm inaccuracy, platform shift and considering the percutaneous approach which minimizes soft tissue pressure, analysis reviewed all available information and concluded the root cause of the deviations is skiving of the surgical tools, resulting in a lateral trajectory of l4 right.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.

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 reported the patient was unable to properly move their foot and they were unable to void their bladder after the procedure.The patient's hospital stay was extended.

• 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: 11821980
• MDR Text Key: 258643657
• Report Number: 3005075696-2021-00057
• 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: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• 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: 04/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2019
• 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 Outcome(s): Required Intervention; Disability; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 82 KG