KYPHON Express II Inflatable Bone Tamp KE202 (UDI 00763000312053)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000312053), received between Oct 21, 2021 and May 2, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T12 KYPHOPLASTY FOR AN INDICATION OF COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BALLOON WAS RUPTURED DURING INFLATION. THE BALLOON INFLATION WAS NOT VISIBLE ON X-RAY, CONTRAST IN INTELLEF LATOR WAS CHECKED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21948978 ↗
• MalfunctionSep 21, 2022Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT THAT WAS USED IN KYPHOPLASTY SURGERY FOR VERTEBRAL COMPRESSION FRACTURE OF L2. IT WAS REPORTED THAT THE BALLOON GOT STUCK IN THE VERTEBRAL BODY AND WHEN TRYING TO REMOVE THE BALLOON THROUGH THE INTRODUCER, THE END OF THE BALLOON BECAME DETACHED FROM THE TETHER AND WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE BALLOON RUPTURED ON INFLATION. THERE CURRENTLY IS NO REVISION SURGERY SCHEDULED OR PLANNED FOR REMOVAL OF THE BALLOON FRAGMENTS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15460839 ↗
• MalfunctionOct 21, 2021Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF TWO COMPRESSION FRACTURES L1 AND L4 INVOLVED IN THE KYPHOPLASTY PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, WHILE INFLATING BALLOON, PRESSURE WAS 300 PSI AND THEN THE BALLOON BURST/RUPTURED. PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIA. PRESSURE PRIOR TO RUPTURE WAS 305 PSI. VOLUME PRIOR TO RUPTURE WAS 2 CC. BALLOON WAS NOT IMPLANTED IN THE PATIENT'S BODY, IT WAS PLACED IN BODY THEN REMOVED. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR 4 MINUTES. THERE WERE NO RUPTURED FRAGMENTS FOUND IN THE PATIENT'S BODY, ONLY CONTRAST MEDIUM WAS FOUND. PROCEDURE WAS COMPLETED WITH NEW PRODUCT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12670474 ↗