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

Device Problems Failure to Align (2522); Activation Failure (3270)

Patient Problem Failure of Implant (1924)

Event Date 08/10/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 the patient had spinal surgery with use of mazor robotic assistance.Per the surgeon, during the procedure the expanding technology failed.Also post op, it was suspected that the screws placed by the mazor were malpositioned from the planned trajectory.Another procedure was required for screw revision and compression of the expandable cage.Fda safety report id # (b)(4).

• Brand Name: MAZOR X NAVIGATION, ROBOTICALLY ASSISTED
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.
• MDR Report Key: 15401748
• MDR Text Key: 299768017
• Report Number: MW5111965
• 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

1 Device was Involved in the Event

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
• 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
• Treatment: SCREWS
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White