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

Model Number	ALL-IN-ONE COMPUTER + PRE-INSTALLED SOFTWARE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Xvision was used on (b)(6) 2022 (l3-l5 fusion).The surgeon had some anatomical issues on the patient's right at each level where the initial trajectories were met with the tap and driver skiving.Trajectories were reset and screws were placed.When examining the c-arm confirmation images, the alignment of the l3 trajectories was different, and no comments were provided for ll4 and ll5 which were found later too medial and caudal.The patient displayed foot drop due to a pinched l4 nerve and required revision surgery.Revision surgery was held, and all screws were removed.Left and right l3, right l4, and right l5 had screws replaced along the previous pathways.The screws in left l4 and left l5 were too medial and caudal, and their trajectories were readjusted in the revision without using the xvs spine system.The investigation concluded that the most likely contributing factor to deviation in the trajectory of left l4 & left l5 pedicle screws is a combination of soft tissue pressure and tool skiving.The most probable cause for the screws' misplacement is due to tool deviation.However, the root cause, in this case, cannot be concluded conclusively.No sw or hw malfunctions were found during the investigation.As this case ended with a required revision case, it was decided that this event will be reported.

• Brand Name: XVISION SPINE SYSTEM (XVS)
• Common Device Name: XVISION SPINE SYSTEM (XVS)
• Manufacturer (Section D): AUGMEDICS LTD.; 2 ha-otsma st.; p.o.b 345; yokneam, 20692 05; IS 2069205
• Manufacturer (Section G): AUGMEDICS LTD.; 2 ha-otsma st.; p.o.b 345; yokneam, 20692 05; IS 2069205
• Manufacturer Contact: shay ramon ; 2 ha-otsma st.; p.o.b 345; yokneam, 20692-05 ; IS 2069205
• MDR Report Key: 16192663
• Report Number: 3016571711-2022-00015
• Device Sequence Number: 11796246
• Product Code: OLO
• UDI-Device Identifier: 07290113780231
• UDI-Public: 07290113780231
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 12/19/2022

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: ALL-IN-ONE COMPUTER + PRE-INSTALLED SOFTWARE
• Device Catalogue Number: ACC00008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown