KYPHON Express II Inflatable Bone Tamp KE202 (UDI 00763000025670)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000025670), received between Aug 23, 2019 and Jan 23, 2020 — classified as 3 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.

• MalfunctionJan 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L3 OSTEOPOROTIC COMPRESSION FRACTURE DUE TO VEHICLE ACCIDENT; AND UNDERWENT BALLOON KYPHOPLASTY AT L3. INTRA-OP, AFTER GAINING BIPEDICULAR ACCESS, BOTH THE BALLOONS WERE INFLATED SIMULTANEOUSLY. DURING INFLATION, THE BALLOON RUPTURED AT 270 PSI. VOLUME PRIOR TO RUPTURE WAS 4 CC. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9620670 ↗
• MalfunctionAug 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY SURGERY AT L1 DUE TO RHEUMATOID ARTHRITIS, OSTEOPOROSIS. INTRA-OP, UNDER FLUOROSCOPIC MONITORING BILATERAL KYPHOPLASTY NEEDLES WERE PLACED THROUGH THE PEDICLES OF L1 INTO THE ANTERIOR ASPECT OF THE VERTEBRA. THE RIGHT BALLOON WAS ABLE TO BE INFLATED 3.5 CC BUT THE LEFT BALLOON RUPTURED AT 2 CC. A REPLACEMENT BALLOON WAS PLACED BUT DURING INFLATION THE RIGHT BALLOON ALSO RUPTURED. THE BALLOONS WERE THEN REMOVED. CEMENT WAS THEN PULLED INJECTED THROUGH EACH CANNULA WITH APPROXIMATELY 3 CC OF REGULAR CEMENT. THERE IS A GOOD BILATERAL DISTRIBUTION OF CEMENT THROUGHOUT THE VERTEBRAL BODY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8924925 ↗
• MalfunctionAug 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY SURGERY AT L1 DUE TO RHEUMATOID ARTHRITIS, OSTEOPOROSIS. INTRA-OP, UNDER FLUOROSCOPIC MONITORING BILATERAL KYPHOPLASTY NEEDLES WERE PLACED THROUGH THE PEDICLES OF L1 INTO THE ANTERIOR ASPECT OF THE VERTEBRA. THE RIGHT BALLOON WAS ABLE TO BE INFLATED 3.5 CC BUT THE LEFT BALLOON RUPTURED AT 2 CC. A REPLACEMENT BALLOON WAS PLACED BUT DURING INFLATION THE RIGHT BALLOON ALSO RUPTURED. THE BALLOONS WERE THEN REMOVED. CEMENT WAS THEN PULLED INJECTED THROUGH EACH CANNULA WITH APPROXIMATELY 3 CC OF REGULAR CEMENT. THERE IS A GOOD BILATERAL DISTRIBUTION OF CEMENT THROUGHOUT THE VERTEBRAL BODY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8924923 ↗