KYPHON Xpander™ Inflatable Bone Tamp K09A (UDI 00643169103061)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169103061), received between Aug 16, 2017 and Jul 6, 2020 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (14 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2020Leak/Splash; Leak/Splash

  PRE OP DIAGNOSIS: OSTEOPOROTIC COMPRESSION FRACTURED PROCEDURE PERFORMED: KYPHOPLASTY WITH BILATERAL BALLOON DISTRACTION INTRA OP, AFTER THE WORKING ACCESS WAS ESTABLISHED, IT WAS PLANNED THAT THE TWO BALLOONS WERE SIMULTANEOUSLY DEPLOYED, BUT BOTH OF THE BALLOONS APPEARED TO BE IN A STATE OF PRESSURE LOSS, AND THERE WAS A CONTRAST AGENT IN THE VERTEBRAL BODY DURING THE SURGERY. AFTER IMPLANTATION, IT WAS PRESSURIZED WITH A PRESSURE PUMP, BUT THE BALLOON COULD NOT BE OPENED AND THERE WAS A CONTRAST AGENT IN THE VERTEBRA. AFTER THE BALLOON WAS REMOVED, IT WAS FOUND THAT THE BALLOON WAS DAMAGED AND THE CONTRAST AGENT WAS LEAKING. THERE WAS A DELAY OF ONE HOUR. AFTER THE BALLOON WAS REMOVED, THE PRESSURE PUMP WAS USED IN VITRO TO OPEN THE BALLOON. IT WAS FOUND THAT THE CONTRAST AGENT WAS SPRAYED AT THE ROOT OF THE CONNECTION BETWEEN THE BALLOON BODY AND THE BALLOON ROD. THERE WERE NO COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10231460 ↗
• MalfunctionJul 6, 2020Leak/Splash; Leak/Splash

  PRE OP DIAGNOSIS: OSTEOPOROTIC COMPRESSION FRACTURED PROCEDURE PERFORMED: KYPHOPLASTY WITH BILATERAL BALLOON DISTRACTION INTRA OP, AFTER THE WORKING ACCESS WAS ESTABLISHED, IT WAS PLANNED THAT THE TWO BALLOONS WERE SIMULTANEOUSLY DEPLOYED, BUT BOTH OF THE BALLOONS APPEARED TO BE IN A STATE OF PRESSURE LOSS, AND THERE WAS A CONTRAST AGENT IN THE VERTEBRAL BODY DURING THE SURGERY. AFTER IMPLANTATION, IT WAS PRESSURIZED WITH A PRESSURE PUMP, BUT THE BALLOON COULD NOT BE OPENED AND THERE WAS A CONTRAST AGENT IN THE VERTEBRA. AFTER THE BALLOON WAS REMOVED, IT WAS FOUND THAT THE BALLOON WAS DAMAGED AND THE CONTRAST AGENT WAS LEAKING. THERE WAS A DELAY OF ONE HOUR. AFTER THE BALLOON WAS REMOVED, THE PRESSURE PUMP WAS USED IN VITRO TO OPEN THE BALLOON. IT WAS FOUND THAT THE CONTRAST AGENT WAS SPRAYED AT THE ROOT OF THE CONNECTION BETWEEN THE BALLOON BODY AND THE BALLOON ROD. THERE WERE NO COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10231437 ↗
• MalfunctionMar 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH L3 COMPRESSION FRACTURE; AND UNDERWENT BALLOON KYPHOPLASTY AT L3 AND L4. INTRA-OP, THE BALLOON RUPTURED WHILE IT WAS BEING USED. THE PROCEDURE WAS HOWEVER COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9863634 ↗
• MalfunctionJul 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY SURGERY AT T8 DUE TO MYELOMA. INTRA-OP, INFLATABLE BONE TAMP BURST. SURGEON STARTED THE PROCEDURE AND ALL THE STEPS WERE FOLLOWED ACCORDING TO THE SURGICAL TECHNIQUE, USED THE DRILL TO REMOVE ALL THE SHARP PIECES OF BONE AND AFTER THAT TOOK FIRST BALLOON AND INSERTED IT INTO THE WORKING CHANNEL "T15D" AND AFTER COMPLETE INSERTION (BOTH THE MARKERS WERE OUTSIDE THE WORKING CHANNEL AT LEAST 5 MM), STARTED INFLATING THE IBT AND AFTER 4 TURNS THE IBT BURST INSIDE THE VERTEBRAL BODY. SURGEON HAD TO INJECT THE CEMENT LIKE VERETEBROPLASTY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8774635 ↗
• MalfunctionDec 7, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE) AND UNDERWENT UNSPECIFIED PROCEDURE. DURING THE SURGERY, THE BALLOON WAS INFLATED, AND IT WAS BROKEN WHEN APPROACHING TO THE CORTICAL BONE OF VERTEBRAL BODY. SINCE IT WAS INFLATED TO THE TARGETED END POINT, THE BALLOON WAS DEFLATED, THE CONTRAST MEDIUM WAS REMOVED FROM THE PATIENT BODY, THE CEMENT WAS INJECTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8144580 ↗
• MalfunctionDec 4, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT, INTRA-OP, THE BALLOON BURST AT 200 PSI. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS A DELAY IN THE SURGERY. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE OCCURRED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8128011 ↗
• MalfunctionOct 17, 2018Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH PRIMARY OSTEOPOROSIS AND UNDERWENT KYPHOPLASTY AT "TH12". DURING SURGERY, AFTER CREATING A ROUTE TO THE VERTEBRAL BODY, BALLOON WAS INSERTED. WHEN TRYING TO EXPAND THE BALLOON,THE BALLOON ON THE RIGHT SIDE DID NOT INFLATE MUCH AND CONTRAST MEDIA LEAKED FROM THE INSERTION PART OF STYLET. METASTASIS WAS ALSO SUSPECTED. MAYBE THE PROBABILITY THAT THE BONE QUALITY WAS HARD WAS LOW. CURETTE WAS NOT USED THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7976399 ↗
• MalfunctionOct 4, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY PRIMARY OSTEOPOROSIS AND UNDERWENT BALLOON KYPHOPLASTY. DURING SURGERY, THE CON TRAST MEDIUM LEAKED WHEN THE BALLOON WAS INFLATED IN THE VERTEBRAL BODY AT L2. THE PRODUCT WAS TAKEN OUT OF THE BODY AND BEING CHECKED, IT SEEMED THAT THERE WAS A CRACK IN THE BALLOON. IBT RUPTURED DURING INFLATION. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIA. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT. THERE WAS A DELAY OF LESS THAN 60 MINUTES. PATIENT'S ISSUE WAS RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7936782 ↗
• MalfunctionJul 4, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY PRIMARY OSTEOPOROSIS AND UNDERWENT BALLOON KYPHOPLASTY. DURING SURGERY, THE CONTRAST MEDIUM LEAKED WHEN THE BALLOON WAS INFLATED IN THE VERTEBRAL BODY AT L2. THE PRODUCT WAS TAKEN OUT OF THE BODY AND BEING CHECKED, IT SEEMED THAT THERE WAS A CRACK IN THE BALLOON. IBT RUPTURED DURING INFLATION. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIA.THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT. THERE WAS A DELAY OF LESS THAN 60 MINUTES. PATIENT'S ISSUE WAS RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7662315 ↗
• InjuryMar 23, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY (BKP) DUE TO PRIMARY OSTEOPOROSIS, COMPRESSION FRACTURE. DURING THE SURGERY, THE IBT (INFLATABLE BONE TAMP) RUPTURED AT HIGH PRESSURE. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. WHEN INSERTING THE BALLOON, DRILLING COULD NOT BE PERFORMED PERFECTLY AND THE BALLOON ON THE RIGHT SIDE COULD NOT ENTER. THE BALLOON ON THE LEFT SIDE WAS SET WITHOUT PROBLEMS. WHEN DRILLING WAS PERFORMED ON THE RIGHT SIDE, THE BALLOON ON THE LEFT SIDE WAS NOT REMOVED. AND THE BALLOON ON THE LEFT SIDE WAS BROKEN DUE TO DRILLING ON THE RIGHT SIDE. THE BALLOON'S MARKER PART REMAINED IN THE PATIENT¿S BODY. SO IT WAS REMOVED AS MUCH AS POSSIBLE WITH THE FORCEPS FROM THE GASTRIC CAMERA THROUGH THE OSTEO INTRODUCER. ALTHOUGH THE POSSIBILITY THAT THE BALLOON REMAINED IN THE PATIENT¿S BODY COULD NOT BE DENIED, ACCORDING TO THE JUDGMENT THAT IT WAS REMOVED SUCCESSFULLY AS MUCH AS POSSIBLE, THE CEMENT WAS INDWELT IN THE PATIENT¿S BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL PRODUCT. THERE WAS A DELAY OF LESS THAN 60 MINUTES AS A RESULT OF THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7365126 ↗
• MalfunctionMar 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY AT L2 DUE TO OSTEOPOROSIS. INTRA-OP, DURING INFLATION THE BALLOON GOT RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7337103 ↗
• MalfunctionDec 8, 2017Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE : COMPRESSION FRACTURE, IT WAS REPORTED THAT INTRA-OP, BALLOON RUPTURED DURING INFLATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. A NEW ONE WAS NOT OPENED TO USE, AND THE BALLOON OF THE OPPOSITE SIDE WAS EXPANDED AS BIG AS IT COULD. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7099304 ↗
• MalfunctionSep 27, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE UNDERWENT BALLOON KYPHOPLASTY AT L3 LEVEL. ON (B)(6) 2017, INTRA-OPERATIVE, AFTER INFLATING BALLOON, THE ANTERIOR PART OF THE BALLOON BROKE WHILE WAITING FOR THE CEMENT TO HARDEN. THE BONE SPUR WAS AT THE PART WHERE THE BALLOON BROKE. PRESSURE PRIOR TO RUPTURE IS 200 PSI. AFTER THAT, THE PLACEMENT SITE WAS CLEANED AND FILLED WITH BONE CEMENT. IT IS UNKNOWN IF PATIENT IS ALLERGIC TO CONTRAST MEDIA. IT IS UNKNOWN IF ANY FRAGMENTS OF BALLOON REMAINS INSIDE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6896577 ↗
• MalfunctionSep 7, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA OP, BALLOON LEAKAGE WAS OBSERVED. THERE WAS CONTRAST AGENT LEAKAGE. THE BALLOON CAME IN CONTACT WITH THE PATIENT. EVENTUALLY THE SURGERY WAS COMPLETED WITHOUT THE BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6847564 ↗
• MalfunctionAug 16, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY DUE TO VERTEBRAL COMPRESSION FRACTURES. INTRA-OP, THE BALLOON RUPTURED. DURING THE OPERATION, BALLOON CONTRAST SYRINGES WERE INJECTED INTO THE BALLOON TO INJECT CONTRAST AGENTS. ANGIOGRAPHY REVEALED THE PRESENCE OF EXTRAVASATION OF CONTRAST AGENTS AT THE END OF THE BALLOON, SO BALLOON RUPTURE WAS JUDGED. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS REPORTED AS THE RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6796588 ↗
• MalfunctionAug 16, 2017Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: TH12 COMPRESSION FRACTURE 6 MONTHS AFTER INJURY IT WAS REPORTED THAT INTRA-OP, THE BALLOON RUPTURED DURING INFLATION ON THE LEFT SIDE. THE BALLOON RUPTURED AT EXPANSION PRESSURE 370-380 PSI. CONTRAST AGENT WAS SUCTIONED IMMEDIATELY. THE BALLOON CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6796586 ↗
• MalfunctionAug 16, 2017Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  PRE-OPERATIVE DIAGNOSIS :PRIMARY OSTEOPOROSIS TYPE OF FRACTURE : COMPRESSION FRACTURE LEVEL OPERATED: L3 PROCEDURE: BALLOON KYPHOPLASTY; IT WAS REPORTED THAT DURING SURGERY, THE BONE TAMP GOT RUPTURED WHILE INSERTING INTO THE VERTEBRAL BODY. CONTRAST MEDIUM LEAKED FROM THE BALLOON. IT WAS REMOVED AND CLEANED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6796583 ↗

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-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-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.