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

Model Number AMCH00005

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Spinal Column Injury (2081)

Event Date 07/28/2020

Event Type  Injury  

Event Description

The event is related to the procedure performed on (b)(6) 2020.The surgeon reported that 3 of the screws deviated in position.The first screw inserted was accurate.During the investigation it was found out the surgeon was working though small incision in open procedure which caused for constant rearrangements of retractors and instrumentation handling in close vicinity of the clamp.The augmedics representative suspects that the clamp closing screw was not fully tightened.It was concluded that the clamp was not tighten enough by the surgeon and therefore was moved by the handling of the retractor or instrumentation.The 3 screws were removed and replaced using fluoro.No additional intervention was required.No additional adverse events were reported.The surgeon was re-trained on indication for fully closed clamp.

• Brand Name: XVISION SPINE SYSTEM (XVS)
• Type of Device: NAVIGATION SYSTEM WITH AUGMENTED REALITY
• Manufacturer (Section D): AUGMEDICS LTD; 1 ha-tsmikha st; yokneam illit, 20692 05; IS 2069205
• MDR Report Key: 10446960
• MDR Text Key: 204191691
• Report Number: 3016566144-2020-00001
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290113780002
• UDI-Public: (01)07290113780002(11)200402
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2020,07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AMCH00005
• Device Catalogue Number: AMCH00005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2020
• Distributor Facility Aware Date: 07/28/2020
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 61