KYPHON Xpander™ Inflatable Bone Tamp K13A (UDI 00858196001178)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00858196001178), received between Mar 22, 2017 and Dec 19, 2018 — 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.

• MalfunctionDec 19, 2018Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE LEVELS OPERATED: TH12 IT WAS REPORTED THAT INTRA-OP, IT WAS FOUND THAT THE BALLOON'S INFLATION WAS NO LONGER SMOOTH AND THAT THE BALLOON RUPTURED. THE OPERATION WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8177636 ↗
• MalfunctionMay 8, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, THE IBT BALLOON RUPTURED DURING INFLATION. NO CONTRAST MEDIUM LEAKAGE IN THE PATIENT¿S BODY WAS REPORTED. NO SYMPTOMS IN THE PATIENT DUE TO CONTRAST MEDIUM LEAKAGE CAUSED BY THE BALLOON BREAKAGE. ANOTHER IBT WAS USED FROM A NEW KIT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6550937 ↗
• MalfunctionApr 21, 2017Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE. IT WAS REPORTED THAT DURING SURGERY, THE BALLOON BURST WHEN IT WAS INFLATED TO ABOUT 3CC . THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT AND NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6510509 ↗
• MalfunctionMar 31, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE UNDERWENT KYPHOPLASTY. INTRA-OP, A BALLOON SUDDENLY BROKE DURING BALLOON INFLATION. IT WAS CONSIDERED THAT IT HAPPENED BECAUSE THE BALLOON TOUCHED THE THING LIKE THORN OF CANCELLOUS BONE. VERTEBRAL HEIGHT WAS RECOVERED ON A CERTAIN LEVEL, SO THAT INTRAVERTEBRAL CLEANING WAS DONE AND FINISHED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6448766 ↗
• MalfunctionMar 22, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PATIENT WITH PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE UNDERWENT KYPHOPLASTY. INTRA-OP, CONTRAST MEDIA LEAKED FROM THE AREA WHERE THE STYLET WAS PULLED OUT OF THE INFLATABLE BONE TAMP (IBT). REPORTEDLY,BALLOONS WERE INFLATED TO 1.5ML ON THE BOTH SIDES OF VERTEBRAL BODY USING LATERAL IMAGE. WHEN THE BALLOONS WERE CONFIRMED BY FRONT IMAGE, STYLET OF IBT WAS PULLED OUT. AT THE TIME OF ADDING INFLATION OF BALLOON, CONTRAST MEDIA LEAKED FROM THE AREA WHERE THE STYLET WAS PULLED OUT. THE SURGEON STOPPED THE INFLATION AND REMOVED THE BALLOON PLACED AT LEFT SIDE. THE SURGEON CHECKED THE BALLOON FOR DAMAGE OUTSIDE THE SURGICAL FIELD. IT WAS JUDGED THAT THE BALLOON WAS NOT BROKEN BECAUSE IT COULD NOT BE INFLATED UNDER THE CONDITION THAT THE STYLET WAS PULLED OUT BUT IT COULD BE INFLATED WITH THE STYLET INSERTED. THE SURGEON DECIDED TO USE THE BALLOON USED ON THE RIGHT SIDE TO THE LEFT SIDE. WHEN IMAGE WAS CHANGED TO THE LATERAL IMAGE, AND RIGHT SIDE OF IBT STYLET WAS PULLED OUT, CONTRAST MEDIA LEAKED SAME AS THAT HAPPENING ON THE LEFT SIDE. THE LEFT SIDE OF BALLOON WAS TRIED TO BE INFLATED UNDER THE CONDITION THAT STYLET WAS INSERTED BUT THE PATIENT¿S BONE WAS HARD,

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6423440 ↗

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-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-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.