VELYS 451611002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034646015), received between Aug 4, 2025 and Aug 4, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A SINGLE POSITION LATERAL SPINE PROCEDURE; THERE WAS SPIN WITH CO SYSTEM WHICH CUT OFF ANTERIOR PORTIONS OF THE BODIES. TRYING TO INSTRUMENT SCREWS. CUT OFF THE COUNT DOWN OF THE MEASUREMENTS TO THE DISTAL TIP. SECOND ISSUE WAS A DEVIATED SCREW THE L4 RIGHT SCREW. THE ARM WAS GREEN AND THE PROJECTION WAS SLIGHT OFF PLANNED SCREW. TROUBLESHOOTING: STILL WITHIN PARAMETERS BUT EXCESSIVE PRESSURE WARNING. THERE WAS EXCESSIVE PRESSURE WITH DRIVER BUT WOULD BACK IT OUT, PLACE KNIFE DOWN AGAIN TO MINIMIZE SOFT TISSUE BUT ONCE DRIVER WAS ENTERED THERE WAS EXCESSIVE FORCE ON AND OFF. PUT THE DRIVER IN AND DEVIATED BY A COUPLE MILLIMETERS - 3MM LATERAL 3MM SUPERIOR. SCREW WAS LATERAL AND SUPERIOR TO PLAN BUT STILL CLINICALLY A SAFE SCREW. SCREW POSITION WAS CONFIRMED BY CIOS SPIN. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. PATIENT TREATMENT WAS NOT DELAYED OR CANCELLED.

  Patient problems: Insufficient Information

  MAUDE report 22698019 ↗