KYPHON Xpander II KyphoPak Tray KPX153RBRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000031589), received between Dec 23, 2020 and Jan 12, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2022Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE SURGEON INFLATION OF SYRINGE BALLON TAMP RUPTURED. SURGEON FLUSHED AREA. USED SECOND BALLOON TAMP. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE IS VERTEBRAL COMPRESSION FRACTURE T11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13234963 ↗
• MalfunctionNov 16, 2021Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A KYPHOPLASTY PROCEDURE IN A PATIENT DIAGNOSED WITH L2 FRACTURE. IT WAS REPORTED THAT THE TAMP RUPTURED AND THE CONTRAST MEDIA LEAKED. THE AREA WAS FLUSHED AND THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. THERE WAS NO PATIENT INJURY/SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12818097 ↗
• MalfunctionDec 23, 2020Burst Container or Vessel; Burst Container or Vessel

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH WITH AN UNKNOWN INDICATION FOR SPINAL THERAPY. IT WAS REPORTED THAT INTRA-OP, IBT FAIL OCCUR DURING THE FIRST ATTEMPT. DURING INFLATION, ONE BALLOON HAD A LEAK OF CONTRAST AND THE OTHER ONE BROKE AT 150 PSI. IBT FAIL DURING THE FIRST INSERTION ATTEMPT INTO THE VERTEBRAL BODY THERE WAS A DELAY IN OVERALL PROCEDURE TIME. FURTHER THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11064121 ↗