VELYS 451611021Recalls & reported problems
Medos International Sàrl · VELYS SPINE ARRAY BASE SET · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034643274), received between Dec 30, 2025 and Feb 27, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product2
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Delivered as Unsterile Product
RECEIVED WITH TAMPER PROOF SEAL COMPLETELY OPEN. NO CASES IMPACTED, PRODUCT WAS ORDERED FOR INTERNAL R&D TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469712 ↗MalfunctionFeb 27, 2026Delivered as Unsterile Product
RECEIVED WITH TAMPER PROOF SEAL COMPLETELY OPEN. NO CASES IMPACTED, PRODUCT WAS ORDERED FOR INTERNAL R&D TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469704 ↗MalfunctionDec 30, 2025Malposition of Device; Malposition of Device
IT WAS REPORTED THAT DURING A T4 TO L1 POSTERIOR SPINAL FUSION PROCEDURE, DURING SCREW THE SURGEON DEEMED THAT THE PHANTOM WAS INACCURATE WHEN T7 AND T8 ON THE LEFT SIDE WERE LATERAL TO PLAN. A SECOND SPIN WAS COMPLETED AND WHEN THEY PLACED THE REST OF THE SCREWS IN THE SEGMENT, 4 OF THE SCREWS WERE CONSIDERED INACCURATE TO PLAN: T6 WAS LATERAL ON LEFT SIDE, T5 ON THE RIGHT SIDE WAS DEEMED MEDIAL, T7 ON RIGHT SIDE WAS DEEMED MEDIAL AND T8 ON THE RIGHT SIDE WAS DEEMED MEDIAL. SOME SCREWS WERE REPLACED WITH FREE HAND NAVIGATION AND OTHERS WERE NOT IN THE SPIN WERE COMPLETED FREE HAND WITHOUT NAVIGATION. ROBOT WAS ON THE PATIENT'S RIGHT SIDE. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923816 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.