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	04/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon utilized a perc pin and xlink for registration.He placed left-sided screws (l1-t9), then proceeded to place the right l2 screw before checking the screws.Neuromonitoring noted decreased l lower extremity sensory and motor signals following t9 screw placement.Upon confirmation scan completion, 4 screws were noted to be medial (left t9, t10, t12, l1) and the right l2 screw was lateral.All 5 screws were removed and redirected following the fixation of a clamp to the spinous process and re-scanning.The surgeon did not feel it was a system or software issue but felt as though the rigidity of the perc pin and softness of the patient's bone led to the issue that occurred.Following the procedure, the patient complained about weakness in l leg but was able to move her foot.Patient status was reported to improve.The probable root cause for the inaccurate screws' placement was a movement of the perc pin inserted in the patient's bone combined with a soft bone structure of the patient.Using a clamp instead of a perc pin resulted in the accurate placement of all re-directed screws.

• 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: 16941009
• Report Number: 3016571711-2023-00003
• Device Sequence Number: 12304765
• 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): 05/16/2023

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: 04/17/2023
• Initial Report FDA Received Date: 05/16/2023
• 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