KYPHON Xpander™ Inflatable Bone Tamp K13A (UDI 00763000311926)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000311926), received between Feb 21, 2020 and Mar 8, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2022Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- PRIMARY OSTEOPOROSIS, COMPRESSION FRACTURE INVOLVED IN THE TH11 BALLOON KYPHOPLASTY PROCEDURE. IT WAS REPORTED THAT AFTER THE BALLOON WAS EXPANDED, ONE SIDE OF THE BALLOON WAS DAMAGED WHEN IT WAS EXCEEDED TO 200 PSI ON BOTH SIDES. AFTER THAT IT WAS REMOVED AND FILLED WITH CEMENT. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR LESS THAN 60 MINUTES. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WAS NO MALFUNCTION WITH THE ENTIRE PRODUCTS REPORTED WITH THE KIT. EVENT OCCURRED IN THE SURGICAL FIELD. ON (B)(6) 2022, RECEIVED UPDATED INFORMATION THAT PRODUCT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13692396 ↗
• MalfunctionDec 2, 2021Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR PATIENT UNDERGOING BALLOON KYPHOPLASTY. THE PRE-OP DIAGNOSIS WAS MENTIONED AS "PRIMARY OSTEOPOROSIS" AND TYPE OF FRACTURE WAS "COMPRESSION FRACTURE". IT WAS REPORTED THAT, THE IBT RUPTURED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING THE REPORTED PRODUCT. IT WAS ASKED BUT UNKNOWN, REGARDING THE RUPTURED FRAGMENTS OF IBT LEFT IN PATIENT OR NOT. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED AND NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. THERE WAS NO DELAY IN PROCEDURE REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12915045 ↗
• MalfunctionFeb 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT UNDERWENT UNKNOWN SURGERY AT L2 DUE TO PRIMARY OSTEOPOROSIS. INTRA-OP, BALLOON HAD BROKEN DURING INFLATION. WHEN BALLOON WAS INSERTED FROM THE LEFT SIDE, THE PRESSURE REACHED 180, THEN THE PRESSURE DECREASED. THE BALLOON BROKE BEFORE THE BALLOON CAME IN CONTACT WITH THE END PLATE. THE SALINE OF THE SYRINGE WAS INSERTED, AND THE CONTRAST MEDIA INSIDE THE VERTEBRAL BODY WAS WASHED AND SUCKED, THEN THE BALLOON ON THE CONTRALATERAL SIDE WAS INFLATED. THE AMOUNT OF CONTRAST MEDIA WAS 2.5 CC. THE OPERATION WAS COMPLETED WITH THE OTHER IBT. THERE WAS DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. A SMALL AMOUNT OF FRAGMENT WAS FOUND, BUT CEMENT WAS INSERTED AND GOT SOLIDIFIED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9739344 ↗

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.