FDA Adverse Event Injury Summary report: N

XVISION SPINE SYSTEM (XVS)

MDR report key: 19228927 · Received May 2, 2024

Report

Report Number
3016571711-2024-00008
Event Type
Injury
Date Received
May 2, 2024
Date of Event
April 4, 2024
Report Date
May 2, 2024
Manufacturer
AUGMEDICS LTD.
Product Code
OLO
PMA / PMN Number
K211188
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
IS
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

AFTER FINISHING INSTRUMENTING ON THE RIGHT SIDE, THE SURGEON SWITCHED SIDES OF THE PATIENT AND FLIPPED THE PATIENT MARKER TO EASE THE NAVIGATION TRACKING. THE PROCEDURE DATA SHOWS THAT THE DEVIATION NATURE OF THE LEFT SIDE TRAJECTORIES SHOWS A SIMILAR DEVIATED DIRECTION FOR BOTH LEFT L5 & LEFT L4. IT IS THEREFORE HYPOTHESIZED THAT WHEN THE PATIENT MARKER WAS FLIPPED, THE PERC PIN OR PERC PIN ADAPTER MOVED, CAUSING A MOVEMENT OF THE SYSTEM'S REFERENCE FRAME. THE PERC PIN PLACEMENT WAS FOUND TO BE RIGID IN BONE, HENCE, IT IS SUSPECTED THAT THE PERC PIN ADAPTER MOVED. ANOTHER POSSIBILITY IS ADDITIONAL PRESSURE FROM THE PROXIMAL END OF THE PERC PIN ABOVE THE PLATFORM OR PATIENT SOFT TISSUE, WHICH COULD ALSO DISTORT THE NAVIGATION. BOTH PROBABLE CAUSES SEEM TO BE RELATED TO NON-OPTIMAL SURGICAL TECHNIQUES. THE SURGEON KEPT ALL 3 SCREWS THAT WERE NAVIGATED WITH THE AUGMEDICS SYSTEM. SINCE ONE OF THE SCREWS WAS REDIRECTED, IT WAS DECIDED TO REPORT THIS EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
449885 XVISION SPINE SYSTEM (XVS) XVISION SPINE SYSTEM (XVS) OLO AUGMEDICS LTD. ALL-IN-ONE COMPUTER + PRE-INSTALLED SOFTWARE NA

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other