KYPHON Xpander II KyphoPak Tray KPX153ABRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000026998), received between Jan 17, 2021 and Apr 12, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 12, 2021Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH COMPRESSION FRACTURE AT T11 AND L1 SUGGESTED FOR SPINAL THERAPY. IT WAS REPORTED SURGEON STATED THE BONE WAS HARD. HE COMPLETED INFLATION WITH OTHER BALLOON TAMP IN KIT WITH NO PROBLEM. RUPTURE OCCURRED DURING INFLATION. NO PATIENT SYMPTOMS REPORTED. CUSTOMER DISCARDED THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11647759 ↗
• MalfunctionJan 17, 2021Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH COMPRESSION FRACTURE AT L1 AND L5 INVOLVED IN KYPHOPLASTY PROCEDURE. LEVELS IMPLANTED- L1 L5. IT WAS REPORTED THAT DURING PROCEDURE WHEN WORKING ON THE SECOND LEVEL WITH A NEW BALLOON TAMP, THE BALLOON RUPTURED. THE IBT FAILED DURING THE FIRST INSERTION ATTEMPT INTO THE VERTEBRAL BODY. WHEN WORKING ON SECOND LEVEL WITH A NEW TAMP, THE GAUGE REGISTERED 237 PSI AND THE BALLOON/TAMP RUPTURED. THERE WAS NO PROBLEM WITH THE EXPANDER 1 BALLOON TAMP. IT IS UNKNOWN WHETHER THE PATIENT WAS ALLERGIC TO THE CONTRAST MEDIA. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. PROCEDURE WAS COMPLETED WITH A NEW PRODUCT. NO ADDITIONAL TREATMENT/SURGERY PERFORMED AS A RESULT OF THIS EVENT. PATIENT WAS NOT HOSPITALIZED PROLONG AS A RESULT OF THE EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11182927 ↗