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); Unspecified Nervous System Problem (4426)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

Analysis of the software export was completed.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.T3 right was planned with medial skiving potentials.Moreover, due to the shape of the anatomy the axial angles of the screws were 17 and 20 degrees, increasing the probability to be subjected to soft tissue pressure when instrumenting, especially considering the proximity to the edge of the incision.Two registration attempts were done during this case, one for each segment.Analysis reviewed the provided ap and obl images.In the approve registration stage, an observable shift was present.No confirmation images were provided to confirm the medial deviation of right t3.Since the right t3 was the last trajectory executed, a platform or patient shift could not be ruled out.Analysis concluded the probable cause of the deviation of t3 right is medial skiving of the tools due to an existing skiving potential in the planning.More possible contributing factors are high angles which may have led to soft tissue pressure, and a shift in registration.Though less likely, platform or patient shift could not be ruled out.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 left t3 trajectory was medial by less than 3.5 mm during an open t3 - l2 procedure.The surgeon planned the case with the manufacturer representative prior to the case.A dual clamp was used to mount the surgical system to the patient.Registration was completed successfully and no shifts were noticed.The surgeon started the case at l2 and all screws were placed accurately prior to reaching right t3.Multiple adjustments were made on the right side due to dual-clamp interference with the planned trajectories.Navigation was used and checked regularly during the case.The surgeon checked instruments on the arm guide and patient anatomy.When the surgeon was drilling the right t3 screw, they noticed csf fluid and the drill had breached in the medial direction.No screw was placed.Navigation was checked prior to drilling t3 due to possible soft tissue pressure at the top of the incision.The patient experienced temporary loss of motor function on the right side.The surgeon aborted the use of the guidance system, remedied the csf leak, repaired the dura, and then aborted the case.The patient was then brought to mri for further analysis.The manufacturer representative believed the deviation was due to soft tissue pressure as a larger incision would have been helpful.The procedure was delayed less than 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12384371
• MDR Text Key: 268689979
• Report Number: 3005075696-2021-00099
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• 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: 08/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2021
• 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): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 57