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	Iatrogenic Source (2498)
Date of Event	09/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a surgical procedure using the renaissance system at (b)(6), back on (b)(6) 2016, the customer called and reported (on (b)(6) 2018) that the patient is suing the clinic because of wound healing issues (wound infection) after a renaissance case.The patient underwent surgery on (b)(6) 2016, for decompression of l3-l4 and spondylodesis with cage l4-l5.The spondylodesis was performed with the renaissance system, kit code used: cqdavsv.Additionally, it was reported that the patient went through a revision surgery.Post operative the l5 left screw was loosened and the patient had a revision surgery on (b)(6) 2016 using the renaissance system, kit code used:ckbsm8x.The patient developed wound healing disorder.The rbt device (i.E., guiding unit) sterile cover sterility assurance was verified, and no deficiencies in the sterilization of the specific lots were identified.This event was determined to be reportable though, due to the revision surgery the patient had to go through.

• 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: 8082388
• Report Number: 3005075696-2018-00032
• Device Sequence Number: 11157972
• Product Code: HAW
• UDI-Device Identifier: 07290109180267
• UDI-Public: 07290109180267
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K120812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2018

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: 10/22/2018
• Initial Report FDA Received Date: 11/17/2018
• 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: 78 YR