KYPHON Xpander™ Inflatable Bone Tamp K09A (UDI 00613994703996)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994703996), received between Feb 16, 2017 and Jun 22, 2020 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2020Retraction Problem; Retraction Problem

  PRE-OPERATIVE DIAGNOSIS: OSTEOPOROSIS COMPRESSION FRACTURE LEVELS IMPLANTED: T12 LEVEL INTRA-OP, THE BALLOON WAS DEPLOYED AND 1ML OF CONTRAST AGENT WAS INJECTED DURING THE SURGERY. THE BALLOON WAS DEVELOPED UNDER THE C ARM. WHEN THE VERTEBRAL BODY MET THE CLINICAL REDUCTION REQUIREMENTS, THE EXPANSION WAS STOPPED AND THE CONTRAST AGENT IN THE BALLOON WITHDRAWN SO THAT THE BALLOON CAN BE RECOVERED AND WITHDRAWN. BUT THE CONTRAST AGENT IN THE BALLOON WAS NOT EXTRACTED. THERE WAS 2 HOURS DELAY IN DELAYED IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10177585 ↗
• MalfunctionFeb 27, 2019Material Rupture; Material Rupture

  TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH PRIMARY OSTEOPOROSIS AND UNDERWENT BALLOON KYPHOPLASTY. DURING THE SURGERY, WHEN INFLATING THE BALLOON IN THE VERTEBRAL BODY, THE BALLOON COULD NOT BE INFLATED AND BECAUSE IT WAS FOUND THAT CONTRAST MEDIUM LEAKED FROM THE BALLOON. THE BALLOON WAS RUPTURED AND DEFORMED. ANOTHER INFLATABLE BONE TAMP WAS USED TO DEAL WITH IT. CURETTE WAS NOT USED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA LEAK. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8373285 ↗
• MalfunctionOct 1, 2018Deflation Problem; Deflation Problem

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE : PRIMARY OSTEOPOROSIS TYPE OF FRACTURE:COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA-OP, THE BALLOON COULD NOT BE DEFLATED. IT COULD BE INFLATED, BUT COULD NOT BE DEFLATED EASILY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7924222 ↗
• MalfunctionJul 19, 2018Material Rupture

  IT WAS REPORTED THAT INTRA-OP, THE BALLOON RUPTURED DURING INFLATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7705144 ↗
• MalfunctionJul 19, 2018Material Rupture

  IT WAS REPORTED THAT INTRA-OP, THE REPORTED BALLOON RUPTURED DURING INFLATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7703622 ↗
• MalfunctionJun 7, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY SURGERY AT L1 DUE TO PRIMARY OSTEOPOROSIS. INTRA-OP, THE BALLOON RUPTURED. NO FRAGMENTS OF THE BALLOON REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTD AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7577162 ↗
• InjuryMay 17, 2018Material Rupture; Material Rupture

  PRE-OP DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE LEVELS IMPLANTED: T12 IT WAS REPORTED THAT ON (B)(6) 2018, INTRA-OP, WHEN PERFORMING THE INSTALLATION WITH ADJUSTING THE POSITION OF THE LEFT BALLOON BEFORE INFLATION, THE TIP OF THE BALLOON WAS STUCK IN THE BONE AND COULD NOT BE MOVED. ONCE THE BALLOON WAS EXPANDED AND ATTEMPTED TO BE REMOVED, IT DID NOT MOVE. THE BALLOON WAS EXPANDED WITH THE RIGHT BALLOON AT THE SAME TIME, AND WAS TRIED TO BE REMOVED AGAIN. IT COULD NOT BE REMOVED. THE OPERATION FOR REMOVING IT WAS REPEATED SEVERAL TIMES BUT IT COULD NOT BE REMOVED. IT COULD NOT BE REMOVED EVEN REMOVING THE INNER NEEDLE AND PERFORMING THE OPERATION WHICH COULD BE ASSUMED. THE INNER NEEDLE WAS REMOVED, AND THE BALLOON COULD MOVE BY BEING TWISTED AND TURNED BACK, BUT IT COULD NOT BE REMOVED. ACCORDING TO THE JUDGMENT OF THE PHYSICIAN, IT WOULD BE REMOVED WITH THE PREPARATION OF THE BALLOON RUPTURED. AFTER DEFLATING THE BALLOON, IT WAS TWISTED AND THE TWISTED PART WAS BLOCKED. REMOVING WAS PERFORMED IN THIS STATE. THE TUBE WAS CUT HALFWAY. THE PART WHICH WAS CUT WAS REMOVED AGAIN WITH USING KOCHER, BUT IT COULD NOT BE REMOVED SUCCESSFULLY. THE NEEDLE EXTE

  Patient problems: Foreign Body In Patient

  MAUDE report 7522559 ↗
• MalfunctionMay 17, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY PROCEDURE DUE TO PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. INTRA-OPERATIVELY, DURING INFLATION BALLOON RUPTURED AT THE TIP. CONTRAST MEDIUM LEAKAGE WAS CONFIRMED DURING BALLOON INFLATION. PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. NO FRAGMENTS OF BALLOON REMAINED INSIDE THE PATIENT. THERE WAS NO DELAY IN PROCEDURE TIME. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6571515 ↗
• MalfunctionFeb 16, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE UNDERWENT BALLOON KYPHOPLASTY AT TH12. INTRA-OP, WHILE PLACING THE BALLOON, IBT(INFLATABLE BONE TAMP) RUPTURED. THE PROCEDURE COMPLETED WITH THE ORIGINAL PRODUCT. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6335116 ↗

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.