KYPHON® Express™ Inflatable Bone Tamp K15B (UDI 00763000312008)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000312008), received between Mar 25, 2020 and Mar 6, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2024Material Rupture; Mechanical Jam; Material Rupture; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY FOR VERTEBRAL COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BALLOON POTENTIALLY MALFUNCTIONED DURING A PROCEDURE. THE BALLOON RADIOPAQUE MARKERS/ BALLOON BECAME STUCK IN THE PATIENT AND BROKE OFF IN THE VERTEBRAL BODY. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843661 ↗
• MalfunctionJan 3, 2022Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCT. THE PRE-OP DIAGNOSIS WAS MENTIONED AS COMPRESSION FRACTURE. IT WAS REPORTED THAT, BALLOON RUPTURED DURING INFLATION. WHILE ATTEMPTING TO WITHDRAW THE DEVICE, PART OF THE POLYMER BALLOON SEPARATED FROM THE BODY OF THE BALLOON AND WAS NOT RETRIEVABLE. THERE WAS NO DELAY IN PROCEDURE REPORTED. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN AND NO HOSPITALIZATION WAS REPORTED.  THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13140499 ↗
• MalfunctionMar 25, 2020Material Rupture; Material Rupture

  PRESSURE PRIOR TO RUPTURE- 300 VOLUME PRIOR TO RUPTURE- 3 ML IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY UNILATERAL AT T8 DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, T8 OSTEOCOOL PROCEDURE WAS COMPLETED. THE PROBES WAS REMOVED AND WAITED FOR 30 SECONDS, THEN THE INFLATABLE BONE TAMPS (IBT) WAS INSERTED AND INFLATED. IT BURST AT LOW PRESSURE AND LOW VOLUME. THERE WAS A CONTRAST OBSTRUCTED VIEW OF CEMENT IMPLANTATION. THE OPERATION WAS COMPLETED USING NEW PRODUCT. THERE WAS A DELAY IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9876506 ↗

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-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-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-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.