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

Model Number	TPL0038
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Iatrogenic Source (2498)
Date of Event	09/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This adverse event is being submitted shortly after the company became aware of new information that been provided - a revision case was performed.
Event or Problem Description
Following a surgical procedure using the renaissance system at (b)(6) hospital, back on (b)(6) 2016, the customer alleged (on (b)(6) 2018) that t2 & t3 right trajectories were medial and that this lead to a revision surgery.

• Brand Name: RENAISSANCE SYSTEM
• Common Device Name: STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD.; pob 3104, 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• MDR Report Key: 8036738
• Report Number: 3005075696-2018-00030
• Device Sequence Number: 1435690
• Product Code: HAW
• UDI-Device Identifier: 07290109180267
• UDI-Public: 07290109180267
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/04/2018

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: 09/27/2016
• Initial Report FDA Received Date: 11/05/2018
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 63