FDA Adverse Event
Injury
Summary report: N
XVISION SPINE SYSTEM (XVS)
MDR report key: 23692134
·
Received December 2, 2025
Report
- Report Number
- 3016571711-2025-00025
- Event Type
- Injury
- Date Received
- December 2, 2025
- Date of Event
- November 5, 2025
- Report Date
- December 2, 2025
- 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
AN L4-L5 MIS PROCEDURE WAS PERFORMED USING A 150 MM PERC PIN. INITIAL REGISTRATION AND LANDMARK CHECKS ON BOTH SIDES WERE CONFIRMED AS ACCURATE. AFTER SCREW PLACEMENT, A LATERAL C-ARM IMAGE SHOWED THE RIGHT L5 SCREW POSITIONED LOW AND WITHIN THE FORAMEN, LEADING TO ITS REMOVAL AND LATER REINSERTION UNDER C-ARM GUIDANCE. THE INVESTIGATION INDICATES THAT THE PERC PIN WAS NOT PLACED WITHIN THE PSIS, RESULTING IN A PLATFORM SHIFT THAT LED TO LOW POSITIONING OF THE RL4 AND RL5 SCREWS RELATIVE TO THE XVS DISPLAY, WITH RL5 BREACHING THE PEDICLE. THE FIRST TWO LEFT-SIDE SCREWS WERE PLACED ACCURATELY. THE LANDMARK CHECK WAS PERFORMED ON THE SKIN RATHER THAN IDENTIFIABLE ANATOMY, LIMITING THE ABILITY TO DETECT MOVEMENT AFTER REGISTRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1898680 | XVISION SPINE SYSTEM (XVS) | XVISION SPINE SYSTEM (XVS) | OLO | AUGMEDICS LTD. | AUGMEDICS WS-CART ASSEMBLY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |