KYPHON Xpander™ Inflatable Bone Tamp K08A (UDI 00858196001154)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00858196001154), received between Feb 20, 2017 and Apr 4, 2019 — classified as 1 injury, 6 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.

• MalfunctionApr 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT INTRA-OP, INFLATABLE BONE TAMP (BALLOON) RUPTURED. NO FRAGMENTS OF THE PRODUCT WERE REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8484014 ↗
• MalfunctionJul 25, 2018Break; Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY AT T9 DUE TO T9 COMPRESSION FRACTURE. INTRA-OP, INFLATABLE BONE TAMP BENT UPON ATTEMPTING TO INSERT IT INTO THE WORKING CANNULA. THE DEVICE CAME IN CONTACT WITH THE PATIENT. AFTER IT BENT, A SECOND INFLATABLE BONE TAMP WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER ISSUES.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7720075 ↗
• MalfunctionJul 25, 2018Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY DUE TO PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. INTRA-OP, RUPTURE OF THE LEFT BALLOON WITH SEVEN TURNS AT 200 PSI WAS CONFIRMED ON THE SCREEN IMAGE. WHEN THE BALLOON WAS REMOVED AND INFLATED OUTSIDE THE OPERATION FIELD, THE RUPTURE SEEMED TO BE A PINHOLE AND CONTRAST MEDIUM LEAKAGE WAS CONFIRMED. NO FRAGMENTS OF THE BALLOON REMAINED INSIDE THE PATIENT'S BODY. A NEW ONE WAS OPENED TO COMPLETE THE PROCEDURE. POST-OP, THERE IS NO INFLUENCE ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7720065 ↗
• MalfunctionJul 13, 2018Burst Container or Vessel

  LEVEL IMPLANTED: THORACIC VERTEBRA 12.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7684739 ↗
• InjuryJun 27, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY AT L3 DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, WHEN TIME CAME TO REMOVE BALLOON FROM VERTEBRAL BODY THE BALLOON WOULD NOT DEFLATE. THE SURGEON DEFLATED THE BALLOON USING A LONG NEEDLE TO PUNCTURE BALLOON. WHEN THE SURGEON ATTEMPTED TO REMOVE THE BALLOON, PART BETWEEN RADIOPAQUE MARKERS BROKE OFF FROM THE SHAFT OF THE BALLOON LEAVING THAT PART IN VERTEBRAL BODY. THE SURGEON PROCEEDED TO STABILIZE BODY WITH CEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL PRODUCT. AS PER THE SURGEON, THE PATIENT WAS OK AFTER THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7640503 ↗
• MalfunctionMar 24, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2017, INTRA-OP, BALLOON RUPTURED DURING INFLATION. THE BALLOON HAD LESS PRESSURE AND THE SURGEON COULD SEE A SHADOW IN THE X-RAY. THE BALLOON WAS REMOVED AND TESTED ON THE TABLE, IT WAS FOUND THAT CONTRAST LIQUID WAS COMING OUT OF A HOLE. PATIENT IS NOT ALLERGIC TO CONTRAST MEDIA. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6430866 ↗
• MalfunctionFeb 20, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH SPINAL FRACTURE UNDERWENT KYPHOPLASTY. INTRA-OP, THE INFLATABLE BONE TAMP(IBT) RUPTURED. THE IBT RUPTURED DURING FIRST INFLATION AT A PRESSURE BELOW 300 PSI. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6342645 ↗

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.