MAUDE Adverse Event Report: MEDTRONIC MAZOR; X NAVIGATION CAMERA

Catalog Number TPL 0063

Device Problem Malposition of Device (2616)

Patient Problem Paralysis (1997)

Event Date 06/22/2021

Event Type  Injury  

Event Description

Spinal fusion completed using mazor robot.Screws were placed per direction of mazor robot.After surgery, pt found to have malpositioned screws resulting in pt injury.

• Brand Name: MAZOR
• Type of Device: X NAVIGATION CAMERA
• Manufacturer (Section D): MEDTRONIC; minneapolis MN
• MDR Report Key: 12174434
• MDR Text Key: 261983254
• Report Number: 12174434
• Device Sequence Number: 1
• Product Code: OLO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/08/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: TPL 0063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2021
• Distributor Facility Aware Date: 06/22/2021
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 64 YR
• Patient Weight: 101