FDA Adverse Event
Injury
Summary report: N
XVISION SPINE SYSTEM (XVS)
MDR report key: 23767033
·
Received December 10, 2025
Report
- Report Number
- 3016571711-2025-00031
- Event Type
- Injury
- Date Received
- December 10, 2025
- Date of Event
- November 3, 2025
- Report Date
- December 10, 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
DURING AN L4-L5 MIS PROCEDURE, POST-PLACEMENT X-RAYS SHOWED THAT FOUR SCREWS WERE POSITIONED TOO FAR CRANIALLY. THE SURGEON PERFORMED A RE-SPIN AND REDIRECTED ALL FOUR SCREWS. NAVIGATION ACCURACY WAS RESTORED AFTER REPEATING THE SCAN AND REGISTRATION, AND THE SCREWS WERE SUCCESSFULLY PLACED. BASED ON THE AVAILABLE INFORMATION, THE SURGEON INDICATED THAT MOVEMENT OF THE REGISTRATION STICKER DURING DRAPE REMOVAL WAS THE MOST LIKELY CAUSE OF THE NAVIGATION DRIFT. NO SYSTEM OR INSTRUMENT MALFUNCTION WAS IDENTIFIED. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2876260 | XVISION SPINE SYSTEM (XVS) | XVISION SPINE SYSTEM (XVS) | OLO | AUGMEDICS LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |