MAUDE Adverse Event Report: AUGMEDICS INC. XVISION SPINE SYSTEM (XVS)

Model Number ALL-IN-ONE COMPUTER + PRE-INSTALLED SOFTWARE

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  Injury  

Event Description

A revision case was done with a plan to remove 4 screws from the previous fusion and then place 8 screws with navigation.Before x-link was completed, pa started using suction to clear blood.Rep advised her to stop as any pressure could alter x-link orientation and render navigation inaccurate.Pa stopped using suction.At this point, the surgeon attempted to remove x-link as he thought the x- link was completed while he was scrubbing in.Rep stopped him and x-link was completed with respiration held.The rep suggested re-spin but the surgeon elected to continue with the procedure.The rep suggested that the surgeon perform a thorough landmark check and if any inconsistencies were present, he should re-spin.The surgeon completed a landmark check, and he deemed the navigation to be accurate.After placing the ll3 screw, the pa begin placing the rl3 screw and stated it didn't feel right.The pa removed the rl3 screw since the depth of the instrument seemed to be "off" on the navigation.At this point, the surgeon elected to re-spin.Before re-spinning, he requested neuromonitoring to stim the ll3 screw and it stimmed at 17.Upon re-spinning, he deemed the ll3 screw to be medial and removed it.After, removing the screws, and re-spinning to acquire the patient's anatomy, the surgeon placed all 8 screws accurately with the xvision system.The accurate placement was confirmed with fluoro it was concluded that the cause for the event is a user error or even misuse, as the surgeon decided to continue with the procedure without re-spinning, even though there was suspicion that the marker moved prior to completing registration.It is decided that this event needs to be reported, as two screws were redirected.No harm was reported to the patient.

• Brand Name: XVISION SPINE SYSTEM (XVS)
• Type of Device: XVISION SPINE SYSTEM (XVS)
• Manufacturer (Section D): AUGMEDICS INC.; 21 s. evergreen ave. suite 230; arlington heights IL 60005
• Manufacturer (Section G): AUGMEDICS INC.; 21 s. evergreen ave. suite 230; arlington heights IL 60005
• Manufacturer Contact: kevin hykes ; 21 s. evergreen ave. suite 230; arlington heights, IL 60005 ; 0018479222
• MDR Report Key: 15875826
• MDR Text Key: 304420711
• Report Number: 3016571711-2022-00012
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290113780231
• UDI-Public: 07290113780231
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ALL-IN-ONE COMPUTER + PRE-INSTALLED SOFTWARE
• Device Catalogue Number: ACC00008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other