MAUDE Adverse Event Report: MAZOR ROBOTICS LTD. RENAISSANCE SYSTEM; STEREOTAXIC INSTRUMENT

Model Number TPL0038

Device Problem Device Operational Issue (2914)

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

Event Date 02/02/2018

Event Type  malfunction  

Event Description

During a surgical procedure using the renaissance system at (b)(6) hospital ((b)(6)) on (b)(6) 2018, due to registration failure on t3 for 6 screws (t2-t4), the surgeon had to abort the use of the renaissance and complete the screw insertion freehand.Trying to troubleshoot the registration issues resulted in a prolongation of surgery by over an hour.

• Brand Name: RENAISSANCE SYSTEM
• Type of Device: STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD.; pob 3104, 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer (Section G): MAZOR ROBOTICS LTD.; pob 3104,5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer Contact: marina hefetz ; pob 3104, 5 shacham st.; north industrial park; caesarea, 30889-00 ; IS 3088900
• MDR Report Key: 7295183
• MDR Text Key: 101132465
• Report Number: 3005075696-2018-00009
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 07290109180267
• UDI-Public: 07290109180267
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120812
• 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: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12 YR