FDA Adverse Event Injury Summary report: N

XVISION SPINE SYSTEM (XVS)

MDR report key: 19925838 · Received August 7, 2024

Report

Report Number
3016571711-2024-00013
Event Type
Injury
Date Received
August 7, 2024
Date of Event
July 8, 2024
Report Date
August 7, 2024
Manufacturer
AUGMEDICS LTD.
Product Code
OLO
PMA / PMN Number
K220905
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
IS
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

IN THIS CASE, THE FELLOW PLACED 2 SCREWS ON THE LEFT L4&L5, PERCUTANEOUSLY. WHEN THE RESIDENT BEGAN RIGHT SIDE, HE REPORTED HIS HEADSET SCREEN WAS BLANK, AM TROUBLESHOOT AND THEN OPTED TO SWITCH TO A DIFFERENT HEADSET. THE RESIDENT STARTED TO LANDMARK CHECK THE RIGHT SIDE. AM, FELLOW, AND RESIDENT ALL NOTED THAT THE BURR APPEARED TO BE IN THE PEDICLE WHEN IT SHOULD HAVE BEEN ON THE NEAR CORTEX. AM SUGGESTED ABORTING THE NAVIGATION TO RE-SPIN. FLUORO WAS POSITIONED AND UPON TAKING A/P AND LATERAL SHOTS IT WAS NOTED THAT THE LEFT L4&L5 SCREWS WERE INACCURATE AND IN THE DISC SPACE. LEFT L4&L5 SCREWS WERE REMOVED AND PLACED UNDER FLUORO. NEUROMONITORING REPORTED NO CHANGE IN SIGNAL. UPON REVIEWING THE SCAN, AM NOTED THAT THE PIN WAS PLACED IN THE SACRUM, NOT PSIS. THE PATIENT ALSO HAS A HIGH BMI WITH POSTERIOR TISSUE THICKNESS AND SKINFOLDS. XLINK WAS PLACED OVER A SKIN FOLD. THE RESIDENT AND FELLOW MAY HAVE EXPERIENCED TISSUE DRIFT FROM THE PATIENT. THE PROBABLE CAUSE FOR THE INACCURACY WAS EITHER A PLATFORM SHIFT AFTER REGISTRATION OR A MOVEMENT OF THE PATIENT MARKER OR X MARKER DURING THE REGISTRATION PROCESS. THIS EVENT SEEMS TO BE CAUSED BY A USER ERROR, RELATED TO PERFORMING A LANDMARK CHECK AT THE SKIN LEVEL, WHICH DIDN'T ENABLE DETECTING THE MOVEMENT OF THE REFERENCE FRAME FOLLOWING REGISTRATION. HOWEVER, SINCE THE INVESTIGATION TEAM CANNOT BE CERTAIN THAT A USER ERROR IS THE ROOT CAUSE, AND DUE TO THE FACT THAT SCREWS WERE REDIRECTED, IT WAS DECIDED TO REPORT THIS EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
265371 XVISION SPINE SYSTEM (XVS) XVISION SPINE SYSTEM (XVS) OLO AUGMEDICS LTD. ALL-IN-ONE COMPUTER + PRE-INSTALLED SOFTWARE

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other