KYPHON Express II KyphoPak Tray KEX202EBRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000026943), received between Aug 13, 2021 and May 4, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED IN BALLOON KYPHOPLASTY (BKP) PROCEDURE USED FOR PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE IS COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BALLOON WAS DAMAGED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE BALLOON WAS RUPTURED WHICH OCCURRED DURING NORMAL USAGE OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21957436 ↗
• MalfunctionJun 14, 2024Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN V ERTEBROPLASTY FOR L4 VERTEBRAL FRACTURE SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. LEVELS IMPLANTED WAS L4. IT WAS REPORTED THAT THERE WAS RUPTURE TO THE BALLOON AND IT WAS ONLY INFLATED IN THE CAUDAL DIRECTION. WHEN THE BALLOON EXPANDED, ONLY THE CAUDAL SIDE EXPANDED; IT DID NOT EXPAND ON THE HEAD SIDE. THE BALLOON WAS DEFLATED TO 0, THE POSITION WAS SLIGHTLY SHIFTED TO THE DORSAL SIDE, AND IT WAS OPENED AGAIN, BUT IN THE SAME MANNER, ONLY THE CAUDAL SIDE EXPANDED, AND THE BALLOON ON ONE SIDE WAS DAMAGED. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT ONE BALLOON WAS RAPTURED AND THE OTHER WAS INFLATED OUTSIDE THE SURGICAL FIELD, BUT IT BECAME SWOLLEN DUE TO DEFLECTION ON ONE SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536231 ↗
• MalfunctionJan 2, 2024Nonstandard Device; Material Deformation; Nonstandard Device; Material Deformation

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REP ORTED PRODUCT. PRE-OP DIAGNOSIS OF PATIENT INCLUDES COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT, THE SHAPE OF THE BALLOON WAS DEFORMED WHEN IT WAS OPENED. THE PRODUCT WAS USED SUCCESSFULLY DURING THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18423704 ↗
• MalfunctionAug 13, 2021Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR L2 VCF. IT WAS REPORTED THAT THE BALLOON RUPTURED WHILE INFLATING. THERE WAS NO DELAY REPORTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12317256 ↗