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

Model Number TPL0059

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Peripheral Nervous Injury (4414); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: asm0206-01r, serial/lot #: (b)(4), udi#: (b)(4). A medtronic representative went to the site to test the equipment. Testing revealed that the surgical arm failed and advanced accuracy test at points 1, 3 and 5 on the left side. The accuracy pointer touched the inner wall of the divot. The surgical arm was replaced. The system then passed the system checkout and was found to be fully functional. The surgical arm was returned for analysis. 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.

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure. It was reported that the patient went to the clinic over the weekend with foot drop that was potentially due to a misplaced screw. Four screws were placed during a single position olif procedure using the guidance system on (b)(6) 2020. An interbody was placed prior to placing the screws. During the procedure, the instrument on the surgeon screen did not match the instrument in relation to the patient. A second snapshot was completed to resolve the issue. The patient did not have to be re-register. No other issues occurred during the procedure. The screws looked to be matched up with the planned trajectories according to confirmation images taken during the procedure; however, after further examination, the left l5 screw was medial by 3. 5-10 mm. The initial procedure was delayed less than an hour. A revision procedure was planned to reposition the screw, but had not been scheduled.

• Brand Name: MAZOR X STEALTH EDITION
• 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10885494
• MDR Text Key: 217701599
• Report Number: 3005075696-2020-00128
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• 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: 10/29/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2018
• 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: 11/23/2020 Patient Sequence Number: 1