KYPHON Xpander KyphoPak Tray KPT2002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000031763), received between Apr 16, 2021 and Jun 4, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN DECOMPRESSION AND ROD REPLACEMENT REVISION SURGERY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT AFTER BALLOON INFLATION, THE TRIGGER WAS SQUEEZED, AND THE HANDLE WAS FULLY PULLED, BUT IT WAS NOT COLLECTED, AND THERE WAS AN ISSUE. AFTER SEVERAL REPETITIONS, IT APPEARED TO HAVE DEFLATED. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WERE NO FRAGMENTS LEFT INSIDE PATIENT BODY AND NO PATIENT SYMPTOMS REPORTED AS A RESULT. SINCE THE BALLOON DID NOT DEFLATE, IT SEEMS THAT IT WAS BROKEN WITH A CURETTE AND DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457071 ↗
• MalfunctionSep 5, 2022Deflation Problem; Deflation Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOP LASTY FOR IMPRESSION FRACTURE L2. IT WAS REPORTED THAT THE BALLOON WAS DILATED WITHOUT ANY PROBLEMS, BUT THE PRESSURE COULDN'T RETURN. THE SURGEON HAD TO TRY A NUMBER OF THINGS SO THAT THE BALLOON COULD BE REMOVED FROM THE VERTEBRAL BODY. THE PROCEDURE WAS COMPLETED WITH ORIGINAL PRODUCT. THERE WAS 30 MINS PROCEDURAL DELAY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15355120 ↗
• MalfunctionApr 16, 2021Material Rupture; Material Deformation; Material Rupture; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR VFC. IT WAS REPORTED THAT DURING THE TREATMENT OF A VERTEBRAL FRACTURE OF L1, THE WORKING CANULA WAS FOUND DETERIORATED WITH THE PASSAGE OF ONE OF THE DM PROVIDED IN THE KIT. THE SURGEON HAD DIFFICULTY INTRODUCING THE FOLLOWING DM INTO THE WORKING CANULA. THIS DEFECTIVE WORKING CANULA DAMAGED THE KYPHOPLASTY BALLOON AND DID NOT ALLOW THE OPERATIVE PROCEDURE TO BE CARRIED OUT AS WELL AS POSSIBLE DUE THE LEAKAGE OF RADIOPAQUE PRODUCT AND THE IMPOSSIBILITY OF INFLATING THE BALLOON PROPERLY. THE DEFECTIVE WORKING CANULA DAMAGED THE KYPHOPLASTY BALLOON. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO SYMPTOMS WERE REPORTED. ON (B)(6) 2021 (B)(4) (REP): ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE EVENT OCCURRED ON (B)(6) 2021. THE SURGEON IS (B)(6). THE PATIENT IS (B)(6) YEARS OLD, (B)(6). ON (B)(6) 2021 (B)(4) (REP): ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE LOT NUMBER IS 220866360. THE REPORTED CANNULA CAME IN CONTACT WITH THE PATIENT. THERE IS NO REVISION AND NO PATIENT COMPLICATIONS INVOLVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11677268 ↗

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.