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U.S. Department of Health and Human Services

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

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AUGMEDICS LTD XVISION SPINE SYSTEM (XVS) NAVIGATION SYSTEM WITH AUGMENTED REALITY Back to Search Results
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.
 
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Brand NameXVISION SPINE SYSTEM (XVS)
Type of DeviceNAVIGATION SYSTEM WITH AUGMENTED REALITY
Manufacturer (Section D)
AUGMEDICS LTD
1 ha-tsmikha st
yokneam illit, 20692 05
IS 2069205
MDR Report Key10446960
MDR Text Key204191691
Report Number3016566144-2020-00001
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
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 Received08/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberAMCH00005
Device Catalogue NumberAMCH00005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/24/2020
Distributor Facility Aware Date07/28/2020
Device Age3 MO
Event Location Hospital
Date Report to Manufacturer07/28/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/25/2020 Patient Sequence Number: 1
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