MAUDE Adverse Event Report: MAZOR ROBOTICS RENAISSANCE SYSTEM; STEREOTAXIC INSTRUMENT, PRODUCT CODE: HAW

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	11/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During renaissance system surgery ((b)(6) 2018, (b)(6) hospital), posterior robotic screws were placed (prone position) at l3/l4/l5.Left screw was deviated medially.Thereafter, the patient had a leg pain and a revision case was performed in order to correct the deviated issue.It was noted during the case that the l5 screws on both sides had tissue pressure which might have pushed the robotic instrumentation medially, as the exposure or the incision was not extended to accommodate the lateral angle of the screws.According to the clinical documentation, no device malfunction occurred during the surgery.

• Brand Name: RENAISSANCE SYSTEM
• Common Device Name: STEREOTAXIC INSTRUMENT, PRODUCT CODE: HAW
• Manufacturer (Section D): MAZOR ROBOTICS; pob 3104, 5 schaham st.; north industrial park; caesarea, 30795 67; IS 3079567
• MDR Report Key: 8188537
• Report Number: 3005075696-2018-00034
• Device Sequence Number: 13982883
• Product Code: HAW
• UDI-Device Identifier: 07290109180267
• UDI-Public: 07290109180267
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 11/22/2018
• Initial Report FDA Received Date: 12/21/2018
• 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: 53 YR
• Patient Weight: 70