MAUDE Adverse Event Report: MAZOR ROBOTICS LTD / MEDTRONIC MAZOR X ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number MAZOR X

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 12/05/2019

Event Type  Injury  

Event Description

While using the mazor navigation / robotic system left side screws of a spinal fusion were in place. The right sided screws were medial displaced and required re positioning. Fda safety report id# (b)(4).

• Brand Name: MAZOR X
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD / MEDTRONIC
• MDR Report Key: 9467182
• MDR Text Key: 170940813
• Report Number: MW5091657
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MAZOR X
• Device Catalogue Number: X
• Device Lot Number: TPL0059
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 12/12/2019 Patient Sequence Number: 1