KYPHON Xpander II KyphoPak Tray KPX153PBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000031565), received between Feb 24, 2025 and Apr 3, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR VERTEBRAL COMPRESSION FRACTURE L2. IT WAS REPORTED THAT THE BALLOON WAS VERY HARD TO PULL OUT, REQUIRING SIGNIFICANT EFFORT BY THE PHYSICIAN, ALTHOUGH IT EVENTUALLY CAME OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21759837 ↗
• MalfunctionFeb 24, 2025Product Quality Problem; Mechanical Jam; Product Quality Problem; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR L1 COMPRESSION FRACTURE. IT WAS REPORTED THAT DURING AN INTRA-OPERATIVE PROCEDURE, A BALLOON WAS INFLATED AND GOT STUCK IN THE CANNULA WHEN ATTEMPTING TO REMOVE IT. ADDITIONALLY, THE BALLOON FAILED TO GO BACK UP THE CANNULA AFTER BEING DEFLATED. THE ISSUE OCCURRED DURING THE FIRST INSERTION ATTEMPT INTO THE VERTEBRAL BODY. DESPITE THESE PROCEDURAL ISSUES, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT, AND THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A DELAY IN THE OVERALL PROCEDURE TIME, BUT NO ADDITIONAL TREATMENT OR SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED IN THE EVENT WAS KYPHOPLASTY. IT IS UNKNOWN IF THE REPORTED ISSUE IS A MANUFACTURING ISSUE OR HAPPENED DURING NORMAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444032 ↗