• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAZOR ROBOTICS LTD. RENAISSANCE STEREOTACTIC DEVICE Back to Search Results
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. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRENAISSANCE
Type of DeviceSTEREOTACTIC 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 Key7914217
MDR Text Key121876380
Report Number3005075696-2018-00021
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K120812
Number of Events Reported1
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 Received09/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTPL0038
Device Catalogue NumberTPL0038
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age6 MO
Event Location No Information
Date Manufacturer Received09/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/27/2018 Patient Sequence Number: 1
-
-