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

Model Number TPL0038

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

Patient Problems Muscle Weakness (1967); Nerve Damage (1979); Neurological Deficit/Dysfunction (1982); Paresis (1998); Spinal Column Injury (2081)

Event Date 09/02/2018

Event Type  Injury  

Event 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
• Type of Device: STEREOTACTIC DEVICE
• Manufacturer (Section D): MAZOR ROBOTICS LTD.; 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer (Section G): MAZOR ROBOTICS LTD.; 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer Contact: ayelet matia ; 5 shacham st.; north industrial park; caesarea, 30889-00 ; IS 3088900
• MDR Report Key: 7914217
• MDR Text Key: 121876380
• Report Number: 3005075696-2018-00021
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 07290109180267
• UDI-Public: 07290109180267
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K120812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• 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
• Device Age: 6 MO
• Date Manufacturer Received: 09/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• 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): Disability
• Patient Age: 55 YR