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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problem Nerve Damage (1979)

Event Date 12/24/2021

Event Type  Injury  

Manufacturer Narrative

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 deviations during a scoliosis correction procedure from t4-l3.The left side of the patient was noted to be concave.The first segment was from t10-l3 and a disposable clamp was placed on the l1 spinous process.There was a medial breach at left l2.The deviation was confirmed with an o-arm scan and the patient's mep signals dropped significantly over time after facetectomies were done.The surgeon believed the segment became movable and the medial screw brushed against the spinal cord causing the drop in motor responses.The screw was removed.The surface of the bone was flattened prior to placing the screw.On the right side, there was soft tissue pressure on the l2 and l3 trajectories that resulted in the surgeon free handing those trajectories.The second segment was from t4-t9 and a dual clamp was placed at t6 and t7.Only one portion of the clamp was used and the other part was loose.All screws were placed accurately on the left side, but there t4-t5 trajectories looked medial.The surgeon decided to freehand t4 and t5 right.The cause of the deviations was not determined.The trajectories were deviated less than 3.5 mm.

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.Analysis reviewed the planning made for the case.L2 bilateral, l3 right and t4 right were planned with high axial angles (>12 degrees).No post op images were provided to confirm the reported deviations, however the analysis examined the 3d reconstruction of the scan & plan study provided.The planned l2, l3 right and t4-t5 right trajectories can be seen in proximity to the incision edges, hence are subjected to soft tissue pressure, which may create difficulties to accommodate the tools without deviating them medially.As reported, the deviations of l2 bilateral, l3 right, t4 and t5 right were medial.Considering the accurate trajectories done in between, platform shift as a root cause seems to be eliminated.Based on all available information, after ruling out a platform shift, considering the open approach and the high angles in the planning, analysis concluded the root cause of the deviation experienced in the or was soft-tissue pressure applied on the tools while instrumenting, resulted in medially deviated l2 bilateral, l3 right, t4 right and t5 right trajectories.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.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: 13231457
• MDR Text Key: 287592390
• Report Number: 3005075696-2022-00003
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109183213
• UDI-Public: 07290109183213
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K182077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2019
• 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