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

Model Number	TPL0038
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blood Loss (2597); Disc Impingement (2655)
Date of Event	08/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This adverse event is being submitted shortly after the company completed an internal retrospective review process of historic records.
Event or Problem 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
• Common Device Name: STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD.; pob 3140, 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• MDR Report Key: 7988255
• Report Number: 3005075696-2018-00024
• Device Sequence Number: 427699
• Product Code: HAW
• UDI-Device Identifier: 07290109180267
• UDI-Public: 07290109180267
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2016
• Initial Report FDA Received Date: 10/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Weight: 70