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

Model Number TPL0038

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 07/07/2016

Event Type  Injury  

Manufacturer Narrative

This adverse event is being submitted shortly after the company completed an internal retrospective review process of historic records.

Event Description

Following two dbs electrode placement procedures using the renaissance system on (b)(6) 2016 at (b)(6), two patients suffered from infection at the burr hole site.This event was reported to mazor three weeks later, on (b)(6) 2016.

• Brand Name: RENAISSANCE SYSTEM
• Type of Device: STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD.; pob 3140, 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer (Section G): MAZOR ROBOTICS LTD.; pob 3140, 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer Contact: ayelet matia ; pob 3140, 5 shacham st.; north industrial park; caesarea, 30889-00 ; IS 3088900
• MDR Report Key: 7988187
• MDR Text Key: 124491760
• Report Number: 3005075696-2018-00023
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 07290109180267
• UDI-Public: 07290109180267
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1901 YR