KYPHON® Express™ Inflatable Bone Tamp KE202Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169143753), received between Jan 30, 2017 and Jul 12, 2019 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT T11 AND T12 DUE TO MELANOMA WITH DIFFUSE BONE TUMORS THROUGHOUT SPINE. INTRA-OP, DURING BALLOON INFLATION, THE BALLOON RUPTURED. PRESSURE OF THE BALLOON PRIOR TO RUPTURE WAS 350 PSI AND VOLUME PRIOR TO RUPTURE WAS 2CC. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. THE PROCEDURE WAS COMPLETED WITH A NEW PRODUCT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME; AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8784119 ↗
• MalfunctionDec 5, 2018Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE LEVELS IMPLANTED: L3 IT WAS REPORTED THAT, INTRA-OP, THE INFLATABLE BONE TAMP(IBT) RUPTURED DURING INFLATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8132029 ↗
• MalfunctionSep 4, 2018Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: OSTEOPOROSIS WITH VERTEBRAL COMPRESSION FRACTURES IT WAS REPORTED THAT INTRA-OP, BALLOON TORE AND WAS STUCK AGAINST THE WORKING CANNULA THAT HAD SLIGHTLY BENT ON INTRODUCTION AS THE BONE WAS SCLEROTIC. BALLOON WOULD NOT PULL OUT SO THE ENTIRE CANNULA WAS REMOVED AND THIS RELEASED THE BALLOON. THE TROCAR WAS REINTRODUCED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7841127 ↗
• MalfunctionJan 16, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY DUE TO METASTATIC SPINAL TUMOR. INTRA-OP, CEMENT WAS DELIVERED FROM RIGHT CONTRALATERAL SIDE OF L3 VERTEBRAL BODY. THE INFLATABLE BONE TAMP RUPTURED AS CEMENT WAS DELIVERED. A CEMENT RESISTANT TECHNIQUE WAS ALSO ATTEMPTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7192753 ↗
• MalfunctionAug 10, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH L2 VERTEBRAL COMPRESSION FRACTURE UNDERWENT BALLOON KYPHOPLASTY AT L2. INTRA-OP, BALLOON RUPTURED DURING INFLATION WITH CONTRAST IN THE VERTEBRAL BODY AND WAS DISINTEGRATED UPON REMOVAL. AFTER THE BALLOON RUPTURED, THE SURGEON HAD DIFFICULTY PULLING OUT THE BALLOON FROM THE CANNULA. PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA.NO PATIENT ISSUES RESULTED FROM THE RUPTURED BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6783815 ↗
• MalfunctionAug 10, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH L2 VERTEBRAL COMPRESSION FRACTURE UNDERWENT BALLOON KYPHOPLASTY AT L2. INTRA-OP, BALLOON RUPTURED DURING INFLATION WITH CONTRAST IN THE VERTEBRAL BODY AND WAS DISINTEGRATED UPON REMOVAL. AFTER THE BALLOON RUPTURED, THE SURGEON HAD DIFFICULTY PULLING OUT THE BALLOON FROM THE CANNULA. PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. NO PATIENT ISSUES RESULTED FROM THE RUPTURED BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6783814 ↗
• InjuryMar 7, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH VERTEBRAL COMPRESSION FRACTURE AT L3 AND L4 UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, BALLOON RUPTURED DURING INFLATION." DISTAL TIP OF THE BALLOON BROKE OFF AND WAS LEFT IN THE VERTEBRAL BODY". PATIENT COMPLICATIONS WERE REPORTED UNKNOWN. THE PATIENT IS NOT ALLERGIC TO CONTRAST MEDIA.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6383045 ↗
• InjuryJan 30, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, RIGHT BALLOON RUPTURED INSIDE THE PATIENT'S VERTEBRAE. THE BALLOON COULD NOT BE RETRIEVED THROUGH CANNULA AND A PIECE OF THE BALLOON WAS LEFT BEHIND IN THE VERTEBRAE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6286511 ↗