KYPHON Xpander KyphoPak Tray KPT1002Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000031657), received between Mar 3, 2022 and Aug 26, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 18, 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.

• MalfunctionAug 26, 2024Leak/Splash; Device Damaged Prior to Use; Leak/Splash; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BKP FOR L2 VERT EBRAL COMPRESSION FRACTURE FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE 3-WAY STOPCOCK WAS DAMAGED WHEN THE KIT WAS UNBOXED. HOWEVER, SETTING WAS PERFORMED BECAUSE THERE SEEMED TO BE NO PROBLEMS WITH THE IBT ITSELF. THERE WERE NO PROBLEMS WITH NEGATIVE PRESSURE AT THE TIME OF SETTING, BUT CONTRAST AGENT LEAKAGE WAS CONFIRMED FROM THE CONNECTOR OF THE TIP OF THE INFLATION SYRINGE AND THE IBT CONNECTION WHEN THE IBT WAS PLACED IN THE VERTEBRAL BODY AND EXTENDED. A NEW KPT1002 WAS UNBOXED AND ANOTHER SET ASSEMBLED, AND BALLOON INFLATION WAS RESUMED AFTER A DELAY OF ABOUT 5 MINUTES. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20062016 ↗
• MalfunctionJul 31, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR PRE-OP DIAGNOSIS OF OSTEOPOROSIS WITH COMPRESSION FRACTURE. IT WAS REPORTED THAT INFLATABLE BONE TAMP WAS RUPTURED DURING INFLA TION. CONTRAST LEAKAGE WAS OBSERVED, SO THE USE OF THE CONTRAST MEDIUM WAS STOPPED, AND AFTER SALINE RINSING WAS PERFORMED. THE CONTRAST MEDIUM WAS REPLACED WITH AN ALTERNATIVE AND THE PROCEDURE WAS CONTINUED. THE PRESSURE IN IBT WAS 240PSI BEFORE IT RUPTURED.  THE PROCEDURE OR TECHNIQUE PERFORMED WAS TH10 BALLOON KYPHOPLASTY. NO TIME DELAY IN PROCEDURE REPORTED AS A RESULT. THERE WAS NO FRAGMENT OF RUPTURED BALLOON WAS LEFT INSIDE PATIENT BODY. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17422905 ↗
• MalfunctionMar 1, 2023Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT WHICH IS USED IN T12 BALLOON KYPHOPLASTY (BKP) SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT WHEN THE BALLOON WAS INFLATED AND THE STYLET WAS REMOVED TO TAKE A FRONTAL VIEW WITH THE C-ARM, CONTRAST MEDIA STARTED LEAKING FROM THE CONNECTION PART, POSSIBLY CAUSING BALLOON BREAKAGE AND THE BALLOON WAS RUPTURED, SO THE BALLOON WAS DEFLATED AND REMOVED. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16458564 ↗
• MalfunctionFeb 3, 2023Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY DUE TO UNKNOWN INDICATION. IT WAS REPORTED THAT THE CONTRAST MEDIA LEAKED INSIDE THEVERTEBRAL BODY DURING BALLOON INFLATION (BALLOON BREAKAGE). THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Extravasation

  MAUDE report 16289674 ↗
• MalfunctionMar 3, 2022Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OP DIAGNOSIS- PRIMARY OSTEOPOROSIS, COMPRESSION FRACTURE INVOLVED IN THE BALLOON KYPHOPLASTY PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, DUE TO THE BREAKAGE OF THE 10M BALLOON, A NEW BALLOON KIT WAS OPENED AND INFLATED. THE LEAKED CONTRAST MEDIA WAS WASHED WITH SALINE AS MUCH AS POSSIBLE. IBT RUPTURED DURING INFLATION. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THE PROCEDURE WAS PERFORMED SUCCESSFULLY BY USING A NEW PRODUCT. PATIENT WAS NOT HOSPITALIZED PROLONG AS A RESULT OF THIS EVENT. EVENT WAS ASSOCIATED WITH THE PATIENT. THE REPORTED PRODUCT WAS DISCARDED FOR THE PATIENT SUSPECTED OF BEING INFECTED. ON 2022-FEB-14, RECEIVED ADDITIONAL INFORMATION THAT CONTRAST MEDIA LEAKED INSIDE THE PATIENT'S BODY, WHEN CEMENT WAS INJECTED, THE CEMENT INJECTION WAS NOT SEEN CLEAR BECAUSE OF THE LEAKAGE. THIS PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13657982 ↗

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.