KYPHON® Express™ II Inflatable Bone Tamp KE102Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000312015), received between Sep 28, 2021 and May 19, 2025 — classified as 1 injury, 2 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 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.

• MalfunctionMay 19, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS VE RTEBROPLASTY THERAPY FOR PRIMARY OSTEOPOROSIS WITH COMPRESSION FRACTURE. LEVELS IMPLANTED WAS 12. IT WAS REPORTED THAT THE BALLOON RUPTURED DURING EXPANSION. THE DOCTOR CONCLUDED THAT IT BURST UPON HITTING HARD BONE WITHIN THE VERTEBRAL BODY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE KE102 IS INCLUDED IN THE KEX102EB AND DISTRIBUTED IN JAPAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044523 ↗
• InjurySep 20, 2023Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPLASTY FOR T12 FRACTURE. IT WAS REPORTED THAT BILATERAL KYPHOPLASTY WAS BEING PERFORMED AND AFTER THE SURGEON USED THE BALLOON TO INFLATE ONE SIDE HE USED THE SAME BALLOON ON THE OTHER SIDE AND THAT'S WHEN THE BALLOON POPPED AND DYE WENT EVERYWHERE THEN ALL A SUDDEN THE PATIENTS BLOOD PRESSURE DROPPED, THE ANESTHESIOLOGIST GAVE FLUIDS TO KEEP THE BP UP AND THE SURGEON FINISHED THE KYPHOPLASTY BUT DIDN'T PUT AS MUCH CEMENT AS HE WOULD HAVE LIKED DUE TO THE ANESTHESIA PROVIDER ASKING TO TERMINATE THE PROCEDURE SO HE COULD GET THE PATIENT'S BP UP. PATIENT WOKE UP AFTERWARDS AND THEY KEPT AN ADDITIONAL HOUR TO MONITOR. THERE WAS NO OTHER SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Extravasation; Low Blood Pressure/ Hypotension

  MAUDE report 17779375 ↗
• MalfunctionSep 28, 2021Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING IBTS IN A KYPHOPLASTY FOR A VERTEBRAE FRACTURE AT T10 AND T12. IT WAS REPORTED THAT THE HCP TRIED TO CURVE THE IBTS BY BENDING THE INNER GUIDEWIRE. WHEN FORCING THE IBTS DOWN THE PATH CREATED IN THE BONE, THE GUIDEWIRE PUSHED FORWARD AND PUNCTURED THE IBTS. THE RUPTURES OCCURRED DURING INFLATION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THERE WAS A DELAY IN OVERALL PROCEDURE TIME BY APPROX. 3 MINUTES. THERE WAS NO IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION NECESSARY OR TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538995 ↗