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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problems Cerebrospinal Fluid Leakage (1772); Nerve Damage (1979); Unspecified Nervous System Problem (4426)

Event Date 11/23/2021

Event Type  Injury  

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.

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that there were deviations and the surgeon could not instrument due to the platform during a t3-s2 open procedure.The surgeon placed screws from left s1 to l1 and all were accurate.On right l4, there was an inferior skive and the patient lost motor control and had a csf leak.The right tib, right ehl, and right gastroc had flatlined and the surgeon was unable to get a response when stimulating.Right l5 and s1 had medial beaches of 1 cm.A neurosurgeon was called in to help repair the csf lead along with the nerves.The surgeon then tried to use the spinous process clamp on l2 and l4 to register l1-s2, but they were unable to do so they continued to the next segment.The next segment was t7-l1 and green values could not be achieved for t11 during registration.The surgeon decided to continue with the other bodies and they found that they were inferior.The surgeon decided to abort the use of the guidance system and complete the procedure freehand.The manufacturer representative believed there was a patient shift that resulted in the issues.The surgeon felt the schanz bridge mounting system had poor rigidity and the schanz connector was too bulky, which caused difficulties in reaching some trajectories.The patient's motor function had not returned after the procedure.The surgeon indicated the nerves were damaged, would not be able to be repaired and resulted in foot drop.The procedure was delayed less than an hour.

Manufacturer Narrative

H3: analysis of the software exports 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<(>&<)>d workstation.Analysis reviewed the planning made for the case.Inferior skiving potential was found in l4 right.In l5 right there was a significant medial skiving potential.Both l4 and l5 right were planned with high angle of over 12 degrees, hence both were prone to soft-tissue pressure.No medial skiving potential was found in s1 right.Analysis reviewed the matching accuracy of the system.The ct-fluoro matching of the vertebrae were determined acceptable.As reported, "on right l4, there was an inferior skive and the patient lost motor control and had a csf leak (¿).Right l5 and s1 had medial breaches of 1 cm." also reported: "the next segment was t7-l1 and green values could not be achieved for t11 during registration.The surgeon decided to continue with the other bodies and they found that they were inferior." post op images of right l4, l5 and s1 deviations weren't provided, as well as post op images of the next segment of t7-l1.Moreover, it was reported that "the surgeon placed screws from left s1 to l1 and all were accurate." intra op images show that there was an inferior deviation of the platform already when the left side screws were executed.Due to the spine rotation in the farther vertebras of l2 and l1, inferior turns into lateral.As reported, "the surgeon felt the schanz bridge mounting system had poor rigidity and the schanz connector was too bulky, which caused difficulties in reaching some trajectories".When closely examining the intra-op images provided, the schanz bridge - schanz connector configuration might have been unstable due to the bridge placement with no "z" shape angulation from ap view.From the images captured during the operation it appears there was no angulation at all.For the next segment of t7-l1, there was inadequate platform fixation as clamps teeth were not all fixated on the spinous processes of l2 and t11, compromising the platform's stability and rigidity.Analysis reviewed the log files provided.The log files indicate no excessive force was applied of the arm.Analysis reviewed all available information and concluded the root cause of the inferior deviation of right l4 is an inadequate platform fixation leading to a platform shift.A skiving potential and soft tissue pressure might have been contributing factors to the direction and magnitude of deviation.The probable root cause of right l5 and right s1 medial deviations is an inadequate platform fixation leading to a platform shift.In right l5 skiving potential and soft tissue pressure might have been contributing factors.The fact that l4-l1 left side screws also deviated inferior and medial further highlights the probability of a platform shift.The probable cause of deviation of trajectories in the upper segment of t7-l1 is an inadequate fixation of platform.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: 13026802
• MDR Text Key: 286456952
• Report Number: 3005075696-2021-00141
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• 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: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2021
• 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 Outcome(s): Other; Disability
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 57 KG