KYPHON® Express™ Inflatable Bone Tamp K15B (UDI 00613994721266)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994721266), received between Dec 21, 2016 and Dec 19, 2017 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K041454); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT WAS PREOPERATIVELY DIAGNOSED WITH VERTEBRAL COMPRESSION FRACTURE AND UNDERWENT AN UNSPECIFIED SURGERY. DURING SURGERY, BALLOON COULD NOT BE INFLATED. A LEAK IN THE SHAFT OF BONE TAMP WAS FOUND DUE TO WHICH THE PRESSURE COULD NOT BUILD UP. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WAS AN UNKNOWN DELAY AS THE RESULT OF THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7127931 ↗
• MalfunctionApr 11, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT UNDERWENT BALLOON KYPHOPLASTY DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, DURING THE INFLATION THE INFLATABLE BONE TAMP AT L2, IT BROKE AT 150 PSI. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6479311 ↗
• MalfunctionMar 3, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH COMPRESSION FRACTURE UNDERWENT BALLOON KYPHOPLASTY AT L2. INTRA-OP, AFTER EXPANSION, THE BALLOON BURST. IT WAS LODGED IN THE CANNULA. PHYSICIAN HAD TO REMOVE CANNULA TO REMOVE THE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6375356 ↗
• InjuryDec 21, 2016Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT WITH VERTEBRAL COMPRESSION FRACTURE, UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, UPON PLACEMENT OF THE OSTEO-INTRODUCER AND BIOPSY, A BALLOON WAS PLACED INTO BROKEN VERTEBRAL BODY. UPON ATTEMPTING TO INFLATE THE BALLOON IT HAD NOT INFLATED. ANOTHER BALLOON HAD NOT INFLATED UNDER FLUOROSCOPY SO THE SURGEON HAD TAKEN THE BALLOON OUT AND HAD CHECKED IT USING RADIOPAQUE DYE. IT HAD LEAKED AS THE SURGEON TURNED THE INFLATION SYRINGE. IT SEEMED LIKE A BOND WAS BAD WHERE THE BALLOON AND SHAFT MET. THAT'S WHERE IT HAD LEAKED. THE SURGEON ENDED UP DOING A VERTEBROPLASTY DUE TO NOT HAVING A BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED. THERE WAS AN OVERALL DELAY IN THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 6192224 ↗
• InjuryDec 21, 2016Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT WITH VERTEBRAL COMPRESSION FRACTURE, UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, UPON PLACEMENT OF THE OSTEO-INTRODUCER AND BIOPSY, A BALLOON WAS PLACED INTO BROKEN VERTEBRAL BODY. UPON ATTEMPTING TO INFLATE THE BALLOON IT HAD NOT INFLATED. ANOTHER BALLOON HAD NOT INFLATED UNDER FLUOROSCOPY SO THE SURGEON HAD TAKEN THE BALLOON OUT AND HAD CHECKED IT USING RADIOPAQUE DYE. IT HAD LEAKED AS THE SURGEON TURNED THE INFLATION SYRINGE. IT SEEMED LIKE A BOND WAS BAD WHERE THE BALLOON AND SHAFT MET. THAT'S WHERE IT HAD LEAKED. THE SURGEON ENDED UP DOING A VERTEBROPLASTY DUE TO NOT HAVING A BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED. THERE WAS AN OVERALL DELAY IN THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 6192223 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041454. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2020 · Apr 24, 2020 · Terminated
  Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Ki
• Z-2390-2020 · Apr 24, 2020 · Terminated
  Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit c
• Z-2391-2020 · Apr 24, 2020 · Terminated
  Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit c
• Z-3175-2011 · Mar 23, 2011 · Terminated
  Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC
• Z-1209-2009 · Feb 4, 2009 · Terminated
  KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.