KYPHON Xpander Inflatable Bone Tamp K13ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000025601), received between Apr 17, 2019 and Jan 16, 2020 — classified as 7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2020Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: PRIMARY OSTEOPOROSIS IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT T11 DUE TO COMPRESSION FRACTURE. BALLON INFLATION WAS BEING PERFORMED FROM THE CONTRALATERAL (LEFT) SIDE. INTRA-OP, THE PRESSURE WAS HARDLY RAISED AND THE CONTRAST MEDIA LEAKED. THE LEAKAGE IN THE CONTRALATERAL VERTEBRAL BODY WAS NOT CONFIRMED. BUT THE PRESSURE BECAME 300 PSI WHEN THE HANDLE WAS ROTATED TWICE. THE SURGEON THOUGHT THIS TO BE STRANGE; THEREFORE, THE SURGEON INFLATED THE BALLOON OUTSIDE THE OPERATION FIELD AND CONFIRMED THAT THE CONTRAST MEDIA LEAKED FROM THE TIP DUE TO THE BREAKAGE OF BALLOON. HENCE, A NEW PRODUCT WAS OPENED TO COMPLETE THE PROCEDURE AND A PRESSURE OF 150 PSI WAS ACHIEVED. WASHING WAS NOT PERFORMED AS THERE WAS ONLY A SMALL AMOUNT OF LEAKAGE. ALTHOUGH THE PROCEDURE WAS DELAYED BY LESS THAN 60 MINUTES DUE TO THIS EVENT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PROBLEMS.THE SURGEON SUSPECTED THAT THE REASON WHY THE CONTRAST MEDIA DID NOT LEAK TO THE PATIENT'S BODY FROM THE BALLOON WAS THAT THE HOLE HAD BEEN BLOCKED BY THE BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9595777 ↗
• MalfunctionJan 16, 2020Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: PRIMARY OSTEOPOROSIS IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT T11 DUE TO COMPRESSION FRACTURE. INTRA-OP, WHEN THE BALLOON WAS INFLATED FROM THE RIGHT SIDE (THE PRESSURE WAS 25 PSI) AND THE HANDLE WAS ROTATED TWICE, IT WAS FOUND THAT THE CONTRAST MEDIA FLOWED BACKWARDS FROM THE CONNECTION PART OF THE BALLOON. THEN, THE BALLOON WAS DEFLATED AND IMAGES WERE CHECKED, WHICH SHOWED THAT THE CONTRAST MEDIA HAD SLIGHTLY LEAKED TO THE PATIENT'S BODY. THE SURGEON WAS RECOMMENDED TO PERFORM WASHING; HOWEVER, WASHING WAS NOT PERFORMED AS THERE WAS ONLY A SMALL AMOUNT OF LEAKAGE. AS A RESULT OF THIS EVENT, THE PRODUCT WAS SUBSTITUTED WITH A NEW ONE, AND A PRESSURE OF 150 PSI WAS ACHIEVED. ALTHOUGH THE PROCEDURE WAS DELAYED BY LESS THAN 60 MINUTES DUE TO THIS EVENT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PROBLEMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9595720 ↗
• MalfunctionJan 10, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY AT THORACIC DUE TO OSTEOPOROTIC VERTEBRAL FRACTURE (OVF). INTRA OP, BALLOON OF INFLATABLE BONE TAMPS (IBT) WAS RUPTURED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AT THIS POINT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9573596 ↗
• MalfunctionOct 5, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THE PATIENT UNDERWENT KYPHOPLASTY SURGERY DUE TO UNKNOWN REASON. INTRA-OP, WHEN THE PRESSURE OF THE BALLOON WAS RAISED TO 200 PSI, THE PRESSURE STOPPED INCREASING AND IT WAS NOTICED THAT THE BALLOON WAS BROKEN (RUPTURE). NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9159618 ↗
• MalfunctionJul 16, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY DUE TO PRIMARY OSTEOPOROSIS. INTRA-OP, THE BALLOON DID NOT DEFLATE EVEN THOUGH THE HANDLE WAS PULLED WHILE THE TRIGGER OF THE INFLATABLE BONE TAMP (IBT ) WAS BEING GRIPPED. SINCE THE BALLOON WOULD DEFLATE WHEN HAVING THE HANDLE ROTATED, THE OPERATION WAS COMPLETED WITHOUT PROBLEMS AS THE BALLOON DEFLATED WHEN THE HANDLE WAS ROTATED. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8792470 ↗
• MalfunctionJun 14, 2019Deflation Problem; Deflation Problem

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA-OP, AFTER INFLATING THE BALLOON, WHEN THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON, IT COULD NOT BE COMPLETELY DEFLATED AND SEEMED IMPOSSIBLE TO BE REMOVED. AFTER TRYING FOR SEVERAL TIMES, THE BALLOON DEFLATED COMPLETELY AND WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED WITH A NEW PRODUCT. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8701600 ↗
• MalfunctionApr 17, 2019Leak/Splash; Leak/Splash

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE: COMPRESSION FRACTURE (INTRAVERTEBRAL CLEFTS). IT WAS REPORTED THAT INTRA-OP, WHEN THE BALLOON WAS INFLATED, CONTRAST MEDIA HAD LEAKED FROM THE TIP, AND THE OPERATION WAS COMPLETED SUCCESSFULLY BY USING ANOTHER KIT. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8522160 ↗

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-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-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-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.