KYPHON Xpander II KyphoPak Tray KPX203RBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000031626), received between Mar 20, 2024 and Mar 16, 2026 — classified as 2 malfunctions.

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

• MalfunctionMar 16, 2026Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED THAT DEVICE USED FOR KYPHOPLASTY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602693 ↗
• MalfunctionMar 20, 2024Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY FOR T12 VERTEBRAL COMPRESSION. IT WAS REPORTED THAT THE DOCTOR ACCESSED THE LEVEL OF THE VERTEBRAL COMPRESSION T12 ACCORDING TO THE INSTRUCTIONS USING THE LEFT PEDICLE ONLY. HE THEN DEPLOYED A SINGLE BALLOON THROUGH THE ACCESS PORT AND ASKED FOR THE CEMENT TO BE MIXED. WHEN THE CEMENT WAS DETERMINED TO BE READY TO INJECT, THE DOCTOR INJECTED ABOUT 1CC OF CEMENT, THEN RETRACTED THE BONE FILLER DEVICE, AND PROCEEDED TO USE THE CURETTE TO SPREAD THE CEMENT OUTWARD FROM ITS ORIGINAL POINT OF INJECTION. THEN HE REMOVED THE CURETTE, AND REINSERTED THE BALLOON CATHETER INTO THE WORKING CANNULA TO FURTHER SPREAD THE CEMENT AND IMPACT INTO THE VERTEBRAL BODY BONE. UPON DOING SO, HE NOTICED THE BALLOON HAD BROKEN. HE NOTED HE HAD FILLED THE BALLOON WITH 2CC OF CONTRAST AND UP TO 100PSI OF PRESSURE. HE THEN DREW BACK ON THE INFLATION SYRINGE HANDLE TO REMOVE AS MUCH OF THE CONTRAST AS POSSIBLE, THEN PULLED OUT THE BALLLOON CATHER. UPON DOING SO HE NOTICED THE LEAD HALF OF THE BALLOON HAD NOT COME OUT. HE THEN ATTEMPTED TO RETRIEVE THE FRONT HALF OF THE BALLOON USING

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18938824 ↗