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

Model Number	TPL0038
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/19/2018
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2018 at (b)(6) private hospital ((b)(6)) a (b)(6) female patient was operated on her l4 vertebra.The surgical plan was to place bilateral pedicle screws (45 x 6.5 mm, everest xt, k2m) in l4 as an extension of a previous l5-s1 fusion surgery.As the left l4 pedicle screw was being implanted, the anaesthetist made the surgeon aware that there was a sudden drop in the patient's blood pressure.A lateral x-ray image was taken of the screws, which showed that the front of the right l4 screw was protruding out of the front of the l4 vertebral body.At this point, the robotic platform and the right l4 pedicle screw was immediately removed.The left l4 pedicle screw remained in situ.The patient was closed up posteriorly and handed over to the vascular surgeons.The patient passed away later that day.

• 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: 7704414
• Report Number: 3005075696-2018-00019
• Device Sequence Number: 14114460
• 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: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2018

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: No Information
• 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: 06/20/2018
• Initial Report FDA Received Date: 07/19/2018
• 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: Death
• Patient Age: 62 YR