KyphoPak™ Express™ Tray KPE1003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169100695), received between Oct 9, 2020 and Oct 9, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2020Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY DUE TO T6 COMPRESSION FRACTURE. IT WAS REPORTED THAT WHEN THE LEFT SIDE BALLOON WAS INFLATED, IT EXPANDED AND MALFORMED (THROUGH ENDPLATE), AND DOCTOR COULD NOT INFLATE THE BALLOON ON RIGHT SIDE AND THERE WAS AN ERROR MESSAGE ON SYRINGE SCREEN. THERE WAS UNSPECIFIED PROCEDURAL DELAY AS A RESULT OF THE EVENT. THERE WERE NO SYMPTOMS REPORTED AS A RESULT OF THE EVENT. PROCEDURAL DELAY WAS 15 MINS. THE PRODUCT WILL BE RETURNED AND REPLACED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10654762 ↗

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.