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 Cerebrospinal Fluid Leakage (1772)

Event Date 05/06/2022

Event Type  Injury  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the system passed all testing and was working as intended.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.Analysis reviewed the planning made for the case.No medial skiving potential was observed in right t9 and right l1.Analysis reproduced registration results for the upper segment.Fluoro image was of low quality with many artifacts, nevertheless, for t9 the ct-fluoro match score showed acceptable values with slight shifts.For the lower segment last registration couldn't be recovered, but log files show acceptable values for l1, however, registration images could not have been controlled for shifts as the registration used for execution was missing.The post-op images provided were taken after re-adjustment of the of right t9.As reported, the patient was noted to have a bmi over 40.Right t9 was adjacent to the skin incision edge with planned axial angle of 13.1 degrees.However, due to spine rotation of approximately 10 degrees to the right at this level, axial trajectory was prone to soft-tissue pressure, pushing the tools medially while drilling.Indeed it was reported that " the surgical arm was sent to the right t9 trajectory, but the trajectory looked medial." even after adjustment soft tissue pressure could not be eliminated under existing conditions.Planned screw diameter was 4 mm, the same diameter as the pedicle of l1, hence no room for any deviation, and so a slight medial deviation of the reported 1.5 mm would have breached the canal.Platform used for operation in the upper segment was a clamp attached to the spinous process of t9.No evidence of platform shift was noticed and the log files show no indication of excessive force applied on the surgical arm.For the lower segment a schanz pin was used.According to the fixation method guidelines, the schanz screw is intended for use in procedures at the sacral and lumbar areas.When using an open surgical approach, the operational range is from s2 through l4; operating outside of this range may compromise the platform stability.It was reported by the representative that "osteotomies and tumor removal was after registration." this also could have led to mobile vertebra or affect expected location of trajectory.The high bmi of the patient may have also contributed to the instability with a waterbed effect.Analysis reviewed all the available information and concluded the probable cause of the deviation of right t9 is soft-tissue pressure applied on the tools while instrumenting, resulted in medially deviated trajectory.Medial deviations in trajectories adjacent the edge of the incision, moreover in morbidly obese patients, are very likely to be due to soft tissue pressure.Soft tissue pressure in combination with the drill can easily push the drilling trajectory 1-2 mm.A registration shift cannot be ruled out as a contributing factor.As to right l1 medial breach, the probable cause is an unstable platform as the trajectory was executed outside of the platform's operational range.Operating outside of this range may compromise the platform stability, which increases with the distance from fixation point.As this was a high bmi patient, a waterbed affect can be a contributing factor.Removal of bone and tumor can also be a contributing factor for spine instability.Given the narrow l1 pedicle, stability and accuracy should have been controlled for with extra care.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 multiple breaches during the t9-l4 fusion with additional resections and modifications.The surgical system was mounted using a clamp and schanz pin.The patient was noted to have a bmi over 40.The case was separated into two segments, t9-t11 and t12-l4.When setting up the case, the 3 define scan failed so a generic work volume was used for the first segment.The surgeon had some difficulty with registration, but they were eventually able to get the segment registered.The surgical arm was sent to the right t9 trajectory, but the trajectory looked medial.The plan was adjusted and the surgical arm was resent to the trajectory.After drilling, the surgeon noticed a csf leak and they found a medial breach using a probe.The placement of the screw was adjusted and the surgeon continued to place screws through t11 left and right without issue and just minor adjustments to plan.Each section was probed by the surgeon and no breaches were found.The surgeon then moved to the second segment.Due to resection, navigation with a percutaneous pin reference frame was used.A generic work volume was used and the surgeon had difficulty with registering all of the vertebrae.Multiple attempts were make with 20 oblique scans, but registration was unable to be completed for l1.A landmark check in navigation was done and the surgeon started drilling on right l1.During drilling, the patient "bucked" so the surgeon stopped drilling.A csf leak and medial breach was found.The use of the guidance system was aborted and the case was completed with navigation.A confirmation spin of the top segment was done and placement of the screws looked good.A confirmation spin of the bottom segment was done and the deviations were approximately 1.5 mm.The screws at t0 and l1 on the right had skived.The procedure was delayed over an hour.

• 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: 14511052
• MDR Text Key: 292694231
• Report Number: 3005075696-2022-00046
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109184838
• UDI-Public: 07290109184838
• 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
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 05/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 98 KG