MAUDE Adverse Event Report: MAZOR ROBOTICS LTD. MAZOR X; STEROTACTIC INSTRUMENT

Model Number TPL0059

Device Problem Device Operational Issue (2914)

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

Event Date 12/11/2017

Event Type  malfunction  

Event Description

During an l3-l5 fusion surgery using the mazor x system at (b)(6) hospital of (b)(6) on (b)(6) 2017, there were minor hardware malfunctions (non-safety).Which resulted in prolongation of surgery by more than an hour.While they were successfully resolved in the or, the troubleshooting collectively consumed over an hour while the patient was already anesthetized.While the patient did not suffer any apparent direct harm, exposure of the patient to the effects of prolonged anesthesia might cause or contribute to a serious injury.

• Brand Name: MAZOR X
• Type of Device: STEROTACTIC INSTRUMENT
• 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: 7184836
• MDR Text Key: 97068173
• Report Number: 3005075696-2018-00003
• 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: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• 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
• Device Age: 13 MO
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/30/2017
• 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: 47 YR
• Patient Weight: 69