MAUDE Adverse Event Report: MAZOR ROBOTICS LTD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Incontinence (1928); Nerve Damage (1979); Pain (1994); Seroma (2069); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Clinical export data and log files were received and thoroughly inspected. Post operative ct scans were received and compared to the pre-operative planning that was prepared for the case. Deviations were noted at the t10 - t12 and l1 right levels. The deviation nature was consistent with the left trajectory appearing medial to the original plan and the right trajectory appearing laterally placed to the original plan. Upon review of the operation flow, the attempt at instrumenting the t10 to l1 region started at l1 left and continued up to t10 left, then down the right side. The t10-l1 segment was performed after the l2-s2 segment. The l2-s2 segment was deemed accurate intra-operatively and was confirmed to be accurate in post-operative scans. After reviewing all available information, no indication of malfunction of the system during the surgery was found. If information is provided in the future, a supplemental report will be issued.

Event Description

This event was previously reported under report #3005075696-2018-00031.

• Manufacturer (Section D): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; 3079567
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; 3079567
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8928698
• MDR Text Key: 155471459
• Report Number: 1723170-2019-04621
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K180307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage