V-STEADY 800039Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08058964723819), received between May 15, 2024 and May 15, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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.

• InjuryMay 15, 2024Migration; Migration

  ON (B)(6) 2021 FLUOROSCOPY GUIDED KYPHOPLASTY AT THE T3/T4 USING V-STEADY BONE CEMENT TO STABILIZE VERTEBRAL BODIES OCCURRED ON PATIENT. SURGEON STATES "RADIOGRAPHS WERE OBTAINED THAT SHOWED GOOD FILLING WITH NO POSTERIOR EXTRAVASATION INTO THE SPINAL CANAL" AND "FINAL RADIOGRAPHS WERE OBTAINED THAT DEMONSTRATED APPROPRIATE FILLING PATTERNS." THE FOLLOWING DAY THE PATIENT RETURNED TO THE ER WITH PAINFUL BREATHING UPON INHALATION, AND EXPERIENCED PAIN IN HER THORACIC AREA WITH COUGHING, ANY MOVEMENT, AND BREATHING. PATIENT'S COMPLICATIONS PERSISTED AND ON (B)(6) 2021 A CT WITH CONTRAST SHOWED EXTRAVASATION OF METHYL METHACRYLATE SHOWING EVIDENCE THAT CEMENT WAS PROPAGATING FROM THE T7 VERTEBRAL BODY INTO A PERIVERTEBRAL DRAINING VEIN AND INTO/AROUND/NEAR THE HEART. AN ECHO (TTE X 4) WAS PERFORMED WHICH CONFIRMED THAT THERE WAS CEMENT IN THE VEINS TO PATIENT'S HEART. PHYSICIAN STATED THE CEMENT LEAKED INTO THE AZYGOS VEIN INTO THE MAIN ATRIUM IN THE HEART. THE CT SCAN REVEALED: "1. LONG LINEAR HYPERDENSE MATERIAL EXTENDING FROM THE T3 AND AND T4 VERTEBRAL BODIES (STATUS POST CEMENT AUGMENTATION), THROUGH THE RIGHT AZYGOS, RIGHT ATRIUM, AND RIGHT VENTRICLE. THIS IS FAVORED TO ALL REPR

  Patient problems: Pulmonary Embolism

  MAUDE report 19323097 ↗