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 00763000025632), received between Jan 15, 2019 and Sep 20, 2019 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY DUE TO ACUTE VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, IT WAS FOUND THAT THE BALLOON WHICH WAS INSERTED IN THE VERTEBRAL BODY DID NOT INFLATE. DISTAL TIP OF BALLOON LEAKED CONTRAST SLOWLY. PRESSURE WAS NOT VERY HIGH AND APPEARED ON IMAGING THAT IT WOULD NOT HOLD INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL PRODUCT. NO PATIENT COMPLICATION WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9096372 ↗
• MalfunctionMay 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY AT T9 DUE TO FALL CAUSES FRACTURE. INTRA-OP, AFTER RE-DRILLING IBT WAS RE-INSERTED, AND ON INFLATION IT GOT BURST. PRESSURE PRIOR TO RUPTURE WAS 550 PSI. VOLUME PRIOR TO RUPTURE WAS 1 CC. SURGEON REMOVED CONTRAST FROM VERTEBRAL BODY BY USING CONTRAST SYRINGE. SURGEON WAS UNABLE TO REMOVE IBT THROUGH CANNULA THEN TRIED TO FIX THE STYE LEAD. FINALLY MOVED THE HANDLE OF THE CANNULA AROUND IN DIFFERENT ANGLES REMOVED THE BALLOON AND CANNULA TOGETHER. NO FRAGMENT OF THE PRODUCT REMAINING IN THE PATIENT. THERE WAS A DELAY OF APPROXIMATELY 10-15 MIN IN PROCEDURE TIME AS A RESULT OF EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8649007 ↗
• MalfunctionJan 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH COMPRESSION FRACTURE AND UNDERWENT BALLOON KYPHOPLASTY (BKP) SURGERY. DURING SURGERY, THE INFLATED BALLOON TAMP (IBT) RUPTURED WHILE INFLATING AT 400PSI. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8251637 ↗