MAUDE Adverse Event Report: AUGMEDICS INC. XVISION SPINE SYSTEM (XVS); NAVIGATION SYSTEM WITH AUGMENTED REALITY

Model Number	XVS HEADSET IPD-64 CLEAR DISPLAY
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Levels l3-l5 were instrumented in an open procedure of a high bmi patient (39.4).Instrumentation started on left top to left bottom.Once the surgeon got to the right side of the patient, he was having difficulties with all the patient's soft tissue and odd pedicles and decided to abort and complete the procedure with the stealthstation.In order to re-register with the stealthstation, a second spin was performed.The surgeon noticed in the scan that l4 screw was placed inferiorly to the pedicle, whereas during the case, the system displayed the position of the screw in the pedicle.The screw was removed and repositioned.The investigation by the company revealed that the calibration of the screwdriver was not performed as indicated in the xvs user manual.In the first two attempts to calibrate the screwdriver according to the xvs user manual instructions, the system notified the user that the screwdriver is too bent and did not enable the successful completion of calibration.At this point, the screwdriver was calibrated using the calibration method that is designed for fixed instruments and not swiveled instruments.Calibration was completed, however, the risk in this system misuse is that the system may display the tracking information inaccurately.The xvs user manual specifically warns the user not to use bent or flexible tools as this may affect the system's accuracy.Hence, it seems that the cause of the event is system misuse.The investigation results will be reviewed with users in the site and the need to follow calibration instructions will be emphasized.

• Brand Name: XVISION SPINE SYSTEM (XVS)
• Common Device Name: NAVIGATION SYSTEM WITH AUGMENTED REALITY
• Manufacturer (Section D): AUGMEDICS INC.; 21 s. evergreen ave.; suite 230; arlington heights IL 60005
• Manufacturer (Section G): AUGMEDICS LTD.; 1 ha-tsmikha st; yokneam, 20692 05; IS 2069205
• Manufacturer Contact: shahar waserman ; 21 s. evergreen ave.; suite 230; arlington heights, IL 60005 ; 8479222721
• MDR Report Key: 13117222
• Report Number: 3016571711-2021-00004
• Device Sequence Number: 19962876
• Product Code: OLO
• UDI-Device Identifier: 07290113780132
• UDI-Public: (01)07290113780132(11)YYMMDD
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K211188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: XVS HEADSET IPD-64 CLEAR DISPLAY
• Device Catalogue Number: (01)07290113780132(21)SN(11)YY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female