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

Model Number	TPL0038
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Nerve Damage (1979); Neurological Deficit/Dysfunction (1982); Paresis (1998); Spinal Column Injury (2081)
Date of Event	09/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
After a surgical procedure using the renaissance system at (b)(6), on (b)(6) 2018 (reported to mazor on september 03, 2018) we received the following report from a senior surgeon (verbatim): "on (b)(6), during a trauma case at 21:00, the operating surgeon has had 1 lateral screw and 1 medial screw at t11.The reason, according to the senior surgeon, is that the operating surgeon used the hover-t platform, but chose the mdb icon on the operation mode, and on t11 when the sw suggested a solution with slider stations other than center, he did not realize that, and proceeded with slider station 21, while in fact he was using the hover-t meaning there is no option for moving the slider.This has resulted in 1 lateral and 1 medial deviation in t11.Afterwards the surgeon has noticed the error and chose center for all trajectories.The surgeon has chosen mdb and proceeded with the solution with slider stations, while in fact he mounted the hover-t platform.The surgeon has stated the patient is suffering from a severe neural deficit, the patient can barely move his legs." a follow up report from mazor clinical sales representative supporting the site a week later: "the patient was able to move his legs and to take a few steps." additional report on patient condition dated sep.26, 2018: "there has been improvement in the patient condition.He will be rehabilitating the coming months.He is independently able to care for himself.He is able to walk longer distances with the aid of a walker-rollator.".

• Brand Name: RENAISSANCE
• Common Device Name: STEREOTACTIC DEVICE
• Manufacturer (Section D): MAZOR ROBOTICS LTD.; 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• MDR Report Key: 7914217
• Report Number: 3005075696-2018-00021
• Device Sequence Number: 930713
• Product Code: HAW
• UDI-Device Identifier: 07290109180267
• UDI-Public: 07290109180267
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K120812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2018

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
• Device Age: 6 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 09/27/2018
• 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: Disability
• Patient Age: 55 YR