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 Code	Neurological Deficit/Dysfunction (1982)
Date of Event	11/16/2016
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-s1 procedure that was performed at (b)(6) us, on (b)(6) 2016.The patient suffered from degenerative disc disease and a procedure was performed in l4-s1 successfully all screws were found to be accurate.However, it was reported that s1 left trajectory seemed to be low in comparison to the plan.Further information regarding this event explained that the surgeon did not take confirmatory images until the k-wire was placed.Furthermore, when passing the rod on the left side, the surgeon encountered high resistance.Consequently, the rod hit the sacrum.Few days after, it was reported that the patient is experiencing some leg pain and motor deficit.

• 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: 7988260
• Report Number: 3005075696-2018-00025
• Device Sequence Number: 13750676
• 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: 11/16/2016
• 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: Disability
• Patient Age: 40 YR
• Patient Weight: 82