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

Model Number TPL0059

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

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

Several attempts were made to submit this adverse event (4 failures were received) due to issues with certificate renewal as well as issues related to the esubmitter (error in method and conclusion code, although do not apear in the actual esubmitter report).Fda help desk was informed and the issue is currently in process (ticket is opened).

Event Description

A complaint was received on (b)96) 2018 from (b)(6).Describing a situation in which a trajectory deviation occurred and resulted in penetration of cement into the canal.The surgery continued as planned and the patient was fine.

• Brand Name: MAZOR X SYSTEM
• Type of Device: STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD.; pob 3104, 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer (Section G): MAZOR ROBOTICS LTD.; pob 3104, 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer Contact: shiran conforti ; pob 3104, 5 shacham st.; north industrial park; caesarea, 30889-00 ; IS 3088900
• MDR Report Key: 8145089
• MDR Text Key: 129746849
• Report Number: 3005075696-2018-00033
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 07290109180465
• UDI-Public: 07290109180465
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163221
• 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: 12/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/08/2018
• Device Age: 1 YR
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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): Required Intervention
• Patient Age: 42 YR