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

Lot Number 4003730621

Device Problem Malposition of Device (2616)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/28/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 the patient underwent a t8-s1 posterior spinal fusion and instrumentation with l2 pedicle subtraction osteotomy for a flat back deformity using the mazor robot.When seen one month post op the patient presented with classic symptoms of left-sided thoracic radiculopathy.Ct of lumbar spine demonstrated questionable implantation of 2 screws on the left side.The patient required a revision surgery during which a total of 6 screws were suspected of having been malpositioned by the robot during the (b)(6) 2022 procedure.Fda safety report id # (b)(4).

• Brand Name: NAVIGATION, ROBOTICALLY ASSISTED
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.
• MDR Report Key: 15401699
• MDR Text Key: 299767199
• Report Number: MW5111960
• 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
• Device Lot Number: 4003730621
• 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: 6 SCREWS
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White