FDA Adverse Event Injury Summary report: N

XVISION SPINE SYSTEM (XVS)

MDR report key: 17442196 · Received August 2, 2023

Report

Report Number
3016571711-2023-00007
Event Type
Injury
Date Received
August 2, 2023
Date of Event
July 4, 2023
Report Date
July 6, 2023
Manufacturer
AUGMEDICS LTD.
Product Code
OLO
UDI-DI
07290113780231
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

IN AN MIS PROCEDURE, A TALL CLAMP WAS PLACED ON THE SP OF T7, AND ITS STABILITY WAS CONFIRMED. UPON INCISION, AN INITIAL LANDMARK CHECK CONFIRMED ANATOMY WITH TACTILE FEEDBACK FROM THE SURGEON, AND THE SCREWS WERE INSTRUMENTED BILATERALLY ON T7 AND T6. A LANDMARK CHECK WAS PERFORMED AT T5, AND THE SURGEON NOTED THAT TACTILE FEEDBACK WAS NOT CORRELATING WITH THE NAV IMAGE SCREEN. AP AND LATERAL IMAGES OF SCREWS INSTRUMENTED SHOWED THAT SCREWS WERE PLACED HIGH AND NOT IN THE PEDICLE LIKE ON THE NAV IMAGES. SURGEON ELECTED NOT TO RE-SPIN AND THE SCREWS WERE REVISED UNDER C-ARM FLUORO, AS WELL AS THE REST OF THE CONSTRUCT. A THOROUGH ANALYSIS WAS CONDUCTED AND SHOWED THE VIRTUAL TRAJECTORIES PRESENTED BY THE XVS SYSTEM APPEAR HIGH BUT NOT IN THE DISK SPACE AS THE SCREWS. HENCE, THERE SEEMS TO BE A DISCREPANCY BETWEEN VIRTUAL AND ACTUAL PLACEMENT. TWO ISSUES WERE FOUND AS POSSIBLE CAUSES FOR THE DISCREPANCY BETWEEN THE REPORTED DEVIATED SCREWS AND THE INCORRECT NAVIGATION INDICATION: 1. MOVEMENT OF X-MARKER POSITION IN RELATION TO PATIENT MARKER DURING REGISTRATION, DUE TO "BREAKING BREATHING" 2. MOVEMENT OF CLAMP DURING INSTRUMENTATION DUE TO BUMPING INTO THE CLAMP NONE OF THE FINDINGS INDICATE A MALFUNCTION OF THE SYSTEM. SINCE THIS EVENT RESULTED IN SCREWS REDIRECTION, WHICH IS CONSIDERED A SERIOUS INJURY, IT WAS DECIDED THAT THIS EVENT NEEDS TO BE REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1458141 XVISION SPINE SYSTEM (XVS) XVISION SPINE SYSTEM (XVS) OLO AUGMEDICS LTD. ALL-IN-ONE COMPUTER + PRE-INSTALLED SOFTWARE NA 07290113780231

Patients

Seq Age Sex Outcome Treatment
1 Unknown Other