KYPHON Xpander Inflatable Bone Tamp K08ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000025588), received between Mar 7, 2019 and Nov 5, 2020 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2020Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH L4 VERTEBRAL FRACTURE SUGGESTED FOR SPINAL THERAPY. EVENT OCCURRED INTRA-OP. IT WAS REPORTED WHILE BALLOON WAS INFLATING AND WITHOUT THE PRESSURE BEING HIGH ENOUGH (AROUND 250-300PSI) THERE WAS A LOSS OF RESISTANCE, THE CUSTOMER REMOVED THE BALLOON AND RAPTURE WAS NOTICED. THERE WAS DELAY IN OVERALL PROCEDURE. NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED. DEVICE IS BEING RETURNED.

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

  MAUDE report 10789776 ↗
• MalfunctionJan 27, 2020Inflation Problem; Inflation Problem

  THERE WAS A DELAY OF LESS THAN 60 MINUTES AS A RESULT OF THIS EVENT. THEY JUST NEEDED SOME MINUTES IN ADDITION TO SET UP A NEW BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9634172 ↗
• MalfunctionOct 5, 2019Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL SURGERY DUE TO VERTEBRAL BODY FRACTURE. INTRA-OP, WHILE INFLATING THE BALLOON INTO THE VERTEBRAL BODY BALLOON RUPTURED. SO CONTRAST LIQUID LEAKED IN THE VERTEBRAL BODY. THE SURGEON REMOVED THE BROKEN BALLOON AND FINISHED THE SURGERY. PATIENT COMPLICATIONS ARE UNKNOWN AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9159550 ↗
• MalfunctionSep 23, 2019Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA-OP, AFTER INFLATION OF THE INFLATABLE BONE TAMP (IBT), THE BALLOON RUPTURED WHILE THE BALLOON WAS INDWELT IN THE PATIENT AND THE CEMENT WAS BEING PREPARED. THE BALLOON RUPTURED AT 80PSI. BECAUSE THE INFLATION WAS ALREADY FINISHED, A SPARE IBT WAS NOT NEEDED AND CEMENT INSERTION WAS PERFORMED AFTER REMOVING THE IBT. NO FRAGMENT OF THE RUPTURED BALLOON REMAINED INSIDE THE PATIENT. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIA; AND NO PATIENT COMPLICATIONS WERE REPORTED. THE DOCTOR BELIEVES THAT THE RUPTURE MIGHT HAVE OCCURRED DUE TO THE EFFECTS OF BONE SPICULE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9102692 ↗
• MalfunctionAug 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY DUE TO LUMBAR VERTEBRAL FRACTURE. THE PATIENT ALSO HAD HIGH BONE DENSITY. INTRA-OP, BALLOON RUPTURED AT 350 PSI PRESSURE. NO FRAGMENT OF THE RUPTURED BALLOON REMAINED INSIDE THE PATIENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME DUE TO THIS EVENT AND NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS BELIEVED THAT THE RUPTURE OCCURRED DUE TO A BONE SPLINTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8926748 ↗
• MalfunctionAug 21, 2019Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE : COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA-OP, DURING INFLATION, THE BALLOON RUPTURED AND CONTRAST MEDIA LEAKED. HENCE, THE PRODUCT WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. NO FRAGMENT OF THE RUPTURED BALLOON REMAINED INSIDE THE PATIENT. PRESSURE AND VOLUME PRIOR TO RUPTURE WERE 100PSI AND 1CC RESPECTIVELY. TOTAL DELAY IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT WAS LESS THAN 60 MINUTES. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8914392 ↗
• MalfunctionAug 21, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA-OP, WHEN TRYING TO INFLATE THE INFLATABLE BONE TAMP (IBT) INTO THE VERTEBRAL BODY, THE BALLOON DID NOT INFLATE AND THE CONTRAST MEDIA LEAKED. HENCE, THE PRODUCT WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. NO FRAGMENT OF THE BALLOON REMAINED INSIDE THE PATIENT. TOTAL DELAY IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT WAS LESS THAN 60 MINUTES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8914374 ↗
• MalfunctionJul 17, 2019Material Rupture; Material Rupture

  PRE OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA-OP, THE IBT BALLOON RUPTURED DURING INFLATION. A NEW IBT WAS OPENED TO COMPLETE THE CASE SUCCESSFULLY. THE DOCTOR SUSPECTED THE EVENT OCCURRED BECAUSE THE DRILLING WAS INSUFFICIENT AND THE SIZE WAS BIG. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE RUPTURED BALLOON REMAINED INSIDE THE PATIENT. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIA. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8797112 ↗
• MalfunctionApr 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED VIA MEDWATCH # MW5085676 THAT INTRA-OP, THE BALLOON POPPED DURING A KYPHOPLASTY ON T12. THE BROKEN PIECES WERE TAKEN OUT WITH NO PATIENT HARM OR INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8548798 ↗
• MalfunctionApr 22, 2019Material Rupture; Material Rupture

  PROCEDURE: BALLOON KYPHOPLASTY IT WAS REPORTED THAT, INTRA-OP, THE INFLATABLE BALLOON TAMP POPPED DURING A KYPHOPLASTY ON THE T12. THE BROKEN PIECES WERE TAKEN OUT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8535081 ↗
• MalfunctionMar 7, 2019Leak/Splash; Leak/Splash

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: LUMBAR SPINE VERTEBRAL FRACTURE TYPE OF PROCEDURE OR TECHNIQUE USED: BALLOON KYPHOPLASTY IT WAS REPORTED THAT INTRA-OP, WHILE INFLATING THE BALLOON IN THE VERTEBRAL BODY, CONTRAST MEDIUM LEAKED FROM THE LOWER PART OF BALLOON. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8398181 ↗

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-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-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.