MAUDE Adverse Event Report: MAZOR ROBOTICS LTD. MAZOR X

Model Number TPL0059

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During surgical procedure using the mazor x system at (b)(6) healthcare (us) on (b)(6) 2017 medial trajectory at l4 due to soft tissue pressure from bilateral retractor resulted in prolongation of more than an hour due to the need to revise the trajectory.Investigation concluded that the device did not malfunction and related risks are within the risk analysis.

• Brand Name: MAZOR X
• Type of Device: MAZOR X
• Manufacturer (Section D): MAZOR ROBOTICS LTD.; 5 shacham st.; north industrial park; caesarea, israel 30889 00; IS 3088900
• Manufacturer (Section G): MAZOR ROBOTICS LTD.; 5 shacham st.; north industrial park; caesarea, israel 30889 00; IS 3088900
• Manufacturer Contact: ayelet matia ; 5 shacham st.; north industrial park; caesarea, 30889-00 ; IS 3088900
• MDR Report Key: 7137365
• MDR Text Key: 95453305
• Report Number: 3005075696-2017-00010
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 07290109180465
• UDI-Public: 07290109180465
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/22/2017
• Device Age: 12 MO
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2017
• 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: 72 YR
• Patient Weight: 93