KYPHON Xpander™ Inflatable Bone Tamp K13A (UDI 00613994703989)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994703989), received between Dec 18, 2018 and Dec 18, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2018Leak/Splash; Leak/Splash

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE LEVELS IMPLANTED: TH12 IT WAS REPORTED THAT INTRA-OP, WHEN INFLATED THE BALLOON AND TRIED TO CHECK THE FRONTAL IMAGE, BOTH THE RIGHT AND LEFT STYLET COULD NOT BE REMOVED FROM THE INFLATABLE BONE TAMP (IBT), AND THE CONTRAST MEDIA LEAKED FROM LEFT SIDE. THE IBT WAS REMOVED, AND WHEN TURNING THE HANDLE TO CONFIRM IF THE BALLOON INFLATED, THE CONTRAST MEDIA SPOUTED OUT FROM THE HOLE OF THE STYLET. SINCE THE CAVITY FORMED, THE IBT WAS NOT RETURNED AND THE CEMENT WAS INJECTED, AND THE OPERATION WAS COMPLETED. THE ONE ON RIGHT SIDE COULD NOT BE REMOVED. THE RIGHT SIDE AND LEFT SIDE WERE OPERATED BY DIFFERENT PHYSICIAN. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8172861 ↗
• MalfunctionDec 18, 2018Leak/Splash; Leak/Splash

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE LEVELS IMPLANTED: TH12 IT WAS REPORTED THAT INTRA-OP, WHEN INFLATED THE BALLOON AND TRIED TO CHECK THE FRONTAL IMAGE, BOTH THE RIGHT AND LEFT STYLET COULD NOT BE REMOVED FROM THE INFLATABLE BONE TAMP (IBT), AND THE CONTRAST MEDIA LEAKED FROM LEFT SIDE. THE IBT WAS REMOVED, AND WHEN TURNING THE HANDLE TO CONFIRM IF THE BALLOON INFLATED, THE CONTRAST MEDIA SPOUTED OUT FROM THE HOLE OF THE STYLET. SINCE THE CAVITY FORMED, THE IBT WAS NOT RETURNED AND THE CEMENT WAS INJECTED, AND THE OPERATION WAS COMPLETED. THE ONE ON RIGHT SIDE COULD NOT BE REMOVED. THE RIGHT SIDE AND LEFT SIDE WERE OPERATED BY DIFFERENT PHYSICIAN. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8172855 ↗

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.