KYPHON Xpander™ II Inflatable Bone Tamp KX203 (UDI 00763000311971)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000311971), received between Jan 11, 2022 and Jan 11, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJan 11, 2022Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH VERTEBRAL COMPRESSION FRACTURE L4 INVOLVED IN THE BALLOON KYPHOPLASTY PROCEDURE. LEVELS IMPLANTED- L4. IT WAS REPORTED THAT INTRA-OPERATIVELY, DURING INFLATION IBT RUPTURED AT TOO LOW OF A PRESSURE AND VOLUME WAS USED WITH ANALOG ATRION INFLATION SYRINGE. PRESSURE PRIOR TO RUPTURE 200PS. BALLOON RUPTURE AT LOW PRESSURE. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. PATIENT WAS NOT HOSPITALIZED PROLONG AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PROCEDURE WAS COMPLETED WITH ORIGINAL PRODUCT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13219834 ↗