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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problem Pain (1994)

Event Date 11/04/2021

Event Type  Injury  

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure. It was reported that the patient had severe pain two days after a l5-s1 tlif procure was completed. Imaging was done and the right l5 screw was deviated by 1-2 mm inferior. During the procedure, a schanz pin was placed in the right psis to mount the surgical system to the patient. A mis ct-fluoro workflow was followed. High skive potential was noted on the trajectories. The surgeon started completed the screws in the following order: left l5, left s1, right l5 and right s1. When drilling l5, the surgeon had to use excessive force to drill due to hard bone and difficulty breaking through the posterior wall. When working on left l5, the surgeon had to re-adjust during the procedure. The manufacturer representative believed the high inferior skive potential and difficulty drilling the bone contributed to the deviation. The procedure was delayed less than an hour. A revision procedure was done to remove both screws at l5. The surgeon decided not to placed screws at that position. The patient was doing well after the revision.

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. 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: 12771070
• MDR Text Key: 280464298
• Report Number: 3005075696-2021-00123
• Device Sequence Number: 1
• Product Code: OLO
• 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

• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 11/08/2021 Patient Sequence Number: 1