KYPHON Xpander™ Inflatable Bone Tamp K13A (UDI 00643169103078)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169103078), received between Jan 12, 2017 and Oct 9, 2018 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2018Material Rupture; Material Rupture

  PROCEDURE: INCLINED BED THERAPY (IBT) TYPE OF FRACTURE: COMPRESSION FRACTURE PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS IT WAS REPORTED THAT INTRA-OP, DURING THE INFLATION OF INCLINED BED THERAPY (IBT), THE CONTRAST MEDIA WAS LEAKING THROUGH A BALLOON. SURGEON OBSERVED A PIN HOLE IN THE BALLOON. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7950146 ↗
• MalfunctionMay 9, 2018Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS PROCEDURE: BALLOON KYPHOPLASTY IT WAS REPORTED THAT DURING INFLATION OF BALLOON, THE BALLOON RUPTURED AT ABOUT 250PSI, THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7497823 ↗
• MalfunctionJul 20, 2017Bent; Bent

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS: ANKYLOSING VERTEBRAL HYPEROSTOSIS AND INTRAVERTEBRAL CLEFTS. FOR WHICH PATIENT UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, AFTER BALLOON WAS INSERTED IN THE VERTEBRAL BODY, THE BALLOON WAS ABLE TO BE INFLATED WITHOUT PROBLEM. WHEN DEFLATING BALLOON, THE MARKER (MADE OF PLATINUM IRIDIUM ALLOY) LOOKED SOMEWHAT DISTORTED. IT WAS REMOVED AND CHECKED VISUALLY. ALTHOUGH NO BREAKAGE WAS OBSERVED, THE SHAFT PART WAS BENT A LITTLE. REPEATED REMOVAL AND INSERTION WAS NOT CONDUCTED. THE MARKER BEFORE INFLATION WAS NORMAL. PRODUCT CAME IN CONTACT WITH THE PATIENT AND NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6728002 ↗
• MalfunctionJan 12, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT BALLOON KYPHOPLASTY AT L1 FOR BURST FRACTURE. INTRA-OP, THE BALLOON DID NOT INFLATE. IT WAS PULLED OUT FROM PATIENT¿S BODY ONCE AND CHECKED. THE INFLATION HAD NO PROBLEM BUT IT WAS FOUND THAT BALLOON WAS FILLED WITH AIR. THE BALLOON INFLATED 2ML BUT THE AIR OCCUPIED ABOUT HALF OF THE SPACE. THE INCISION WAS CLOSED WITH INFLATION AND FILLING OF CEMENT ON ONLY ONE SIDE. AFTER THE SURGERY, BALLOON WAS CHECKED AND A SMALL HOLE ,WHICH WAS NOT ABLE TO BE SEEN VISUALLY, WAS FOUND AT THE BASE OF THE BALLOON (IT WAS FOUND BECAUSE LEAKAGE OF CONTRAST MEDIA WAS OBSERVED). PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WAS A DELAY OF LESS THAN 60 MINS IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO FRAGMENT OF THE DEVICE REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. DOCTOR COMMENTED THAT THE EVENT WAS EXPECTED BECAUSE THE PATIENT¿S BONE WAS HARD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6244736 ↗

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.