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

Model Number TPL0038

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

Patient Problems Blood Loss (2597); Disc Impingement (2655)

Event Date 08/11/2016

Event Type  Injury  

Manufacturer Narrative

This adverse event is being submitted shortly after the company completed an internal retrospective review process of historic records.

Event Description

The reported event is related to a l4-l5 procedure that was performed at (b)(6) medical center', us, on (b)(6) 2016.During the procedure, upon sending the rbt to l4 left trajectory, the surgeon did not change the rbt device's station on the platform according to the software instructions.Therefore, the trajectory was drilled from the wrong station which led to inaccuracy.Consequently, the surgeon drilled l4 left trajectory inside the disc space.Flouro shot confirmed the reported finding.Surgeon increased dissection and used bovie to contain the bleeding.Due to drop in blood pressure the surgeon called in a vascular surgeon.Finally, the case was aborted due to an excessive drop in blood pressure and the patient was brought back to complete the surgery the following day.The procedure was performed with the renaissance system successfully with no further complications.There was no residual damage to the patient from the incident.

• Brand Name: RENAISSANCE SYSTEM
• Type of Device: STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD.; pob 3140, 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer (Section G): MAZOR ROBOTICS LTD.; pob 3140, 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer Contact: ayelet matia ; pob 3140, 5 shacham st.; north industrial park; caesarea, 30889-00 ; IS 3088900
• MDR Report Key: 7988255
• MDR Text Key: 124491475
• Report Number: 3005075696-2018-00024
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 10/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2015
• 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): Other
• Patient Age: 75 YR
• Patient Weight: 70