FDA Adverse Event
Malfunction
Summary report: N
XVISION SPINE SYSTEM (XVS)
MDR report key: 23485738
·
Received November 6, 2025
Report
- Report Number
- 3016571711-2025-00021
- Event Type
- Malfunction
- Date Received
- November 6, 2025
- Date of Event
- October 2, 2025
- Report Date
- November 6, 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 A SURGICAL PROCEDURE, A COMPONENT OF A SWIVEL ADAPTOR DETACHED WHILE IN USE. THE EVENT WAS CONTAINED IMMEDIATELY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT IMPACT. THE INVESTIGATION CONCLUDED THAT THE EVENT WAS AN ISOLATED ASSEMBLY-RELATED OCCURRENCE, WITH NO DESIGN, MATERIAL, OR TOOLING DEFICIENCIES IDENTIFIED. THE ASSEMBLY PROCESS HAS SINCE BEEN REFINED TO PREVENT RECURRENCE. ALTHOUGH THE POTENTIAL FOR A SPRING TO REMAIN INSIDE THE PATIENT COULD THEORETICALLY LEAD TO A TISSUE RESPONSE, THE RISK HAS BEEN ANALYZED, AND IT WAS DETERMINED THAT SUCH A SCENARIO WOULD NOT POSE A HEALTH HAZARD. THE CASE WAS REPORTED DUE TO THE DEVICE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2688284 | XVISION SPINE SYSTEM (XVS) | XVISION SPINE SYSTEM (XVS) | OLO | AUGMEDICS LTD. | SWIVEL 6-7.5MM UNIVERSAL TOOL ADAPTER LEG UP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |