MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. MEDTRONIC MAZOR X NAVIGATION, ROBOTICALLY ASSISTED; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number MAZOR X

Device Problem Failure to Align (2522)

Patient Problems Failure of Implant (1924); Nerve Damage (1979)

Event Date 07/25/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 the patient had a mazor robot assisted spine surgery.The patient experienced lower extremity radiculopathy and a ct if the spine was performed on (b)(6) 2022.The patient was readmitted on (b)(6) 2022 for a revision related to suspected misaligned screws.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC MAZOR X NAVIGATION, ROBOTICALLY ASSISTED
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.
• MDR Report Key: 15401708
• MDR Text Key: 299768464
• Report Number: MW5111961
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/07/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAZOR X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White