MAUDE Adverse Event Report: MAZOR ROBOTICS LTD. MAZOR X; STEREOTACTIC DEVICE

Model Number TPL0059

Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During surgical procedure using the mazor x system at presbyterian hospital of plano (us) on (b)(6) 2018, shoulder shift requiring re-registration multiple times due to system hardware malfunction experienced at the site resulted in prolongation of surgery by more than an hour, while the patient was already anesthetized.

• Brand Name: MAZOR X
• Type of Device: STEREOTACTIC DEVICE
• Manufacturer (Section D): MAZOR ROBOTICS LTD.; 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer (Section G): MAZOR ROBOTICS LTD.; 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer Contact: ayelet matia ; 5 shacham st.; north industrial park; caesarea, 30889-00 ; IS 3088900
• MDR Report Key: 7624334
• MDR Text Key: 111851597
• Report Number: 3005075696-2018-00017
• 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: K180307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 05/21/2018
• Device Age: 1 YR
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• 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 Age: 75 YR
• Patient Weight: 95