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); Nerve Damage (1979); Unspecified Nervous System Problem (4426)

Event Date 11/23/2021

Event Type  Injury  

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.

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure. It was reported that there were deviations and the surgeon could not instrument due to the platform during a t3-s2 open procedure. The surgeon placed screws from left s1 to l1 and all were accurate. On right l4, there was an inferior skive and the patient lost motor control and had a csf leak. The right tib, right ehl, and right gastroc had flatlined and the surgeon was unable to get a response when stimulating. Right l5 and s1 had medial beaches of 1 cm. A neurosurgeon was called in to help repair the csf lead along with the nerves. The surgeon then tried to use the spinous process clamp on l2 and l4 to register l1-s2, but they were unable to do so they continued to the next segment. The next segment was t7-l1 and green values could not be achieved for t11 during registration. The surgeon decided to continue with the other bodies and they found that they were inferior. The surgeon decided to abort the use of the guidance system and complete the procedure freehand. The manufacturer representative believed there was a patient shift that resulted in the issues. The surgeon felt the schanz bridge mounting system had poor rigidity and the schanz connector was too bulky, which caused difficulties in reaching some trajectories. The patient's motor function had not returned after the procedure. The surgeon indicated the nerves were damaged, would not be able to be repaired and resulted in foot drop. 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13026802
• MDR Text Key: 286456952
• Report Number: 3005075696-2021-00141
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• 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: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2021
• 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 Treatment Data

Date Received: 12/17/2021 Patient Sequence Number: 1