KYPHON Xpander Inflatable Bone Tamp K09ARecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00763000025595), received between Jan 23, 2019 and Jun 17, 2021 — classified as 1 injury, 34 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (22 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2021Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF OSTEOPOROTIC COMPRESSION FRACTURE IN NEED OF VERTEBROPLASTY IN SPINAL THERAPY. IT WAS REPORTED THAT DURING THE SURGERY, IT WAS FOUND THAT THE BONE EXPANSION BALLOON WAS RUPTURED AND COULD NOT BE USED NORMALLY. THE PATIENT HAD BEEN REPLACED WITH A NEW BALLOON AND COMPLETED THE SURGERY. THERE WAS A DELAY OF LESS THAN 60 MINS REPORTED. THE PATIENT IS CURRENTLY HOSPITALIZED FOR OBSERVATION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12014462 ↗
• MalfunctionMay 20, 2021Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT TYPE FOR LUMBAR FRACTURES. IT WAS REPORTED THAT DURING THE OPERATION, IT WAS FOUND THAT THE SYRINGE A08A HAD NO PRESSURE REACTION, AND THE BALLOON K09A LEAKED AND COULD NOT BE USED NORMALLY. A NEW SYRINGE A08A AND BALLOON K09A WERE REPLACED COMPLETE THE OPERATION, AND THE PATIENT WAS HOSPITALIZED FOR 3 OR 4 DAYS AFTER THE OPERATION FOR OBSERVATION AND HAS BEEN DISCHARGED FROM THE HOSPITAL. THERE WERE NO PATIENT COMPLICATIONS/SYMPTOMS AS A RESULT OF THIS EVENT. THERE WAS A SLIGHT DELAY, BUT IT DID NOT AFFECT THE OVERALL PROCEDURE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853805 ↗
• MalfunctionDec 25, 2019Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT PATIENT UNDERWENT UNKNOWN SURGERY. INTRA-OP, BALLOON RUPTURED DURING INFLATION. THE CONTRAST MEDIA LEAKED AND THE PRESSURE (PSI VALUE) BECAME ZERO(AS SEEN IN THE MONITOR). THEREFORE, ANOTHER PRODUCT WAS USED. PATIENT COMPLICATION ARE UNKNOWN AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9517650 ↗
• MalfunctionDec 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS VERTEBROPLASTY DUE TO COMPRESSION FRACTURE OF PRIMARY OSTEOPOROSIS. INTRA-OP, AFTER IBT PREPARATION, THE ERROR OCCURRED ON THE DIGITAL SCREEN, THE BALLOON WAS INSERTED WITHOUT SEEING THE DIGITAL SCREEN AND WAS INFLATED, AND THE BALLOON RUPTURED AT ABOUT THE THIRD INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE NEW PRODUCT AND WITHOUT ANY DELAY. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9399787 ↗
• MalfunctionNov 22, 2019Material Rupture; Material Rupture

  TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY DUE TO ADJACENT VERTEBRAL FRACTURE. INTRA-OP, THE BALLOON RUPTURED DURING INFLATION. THE PRESSURE DURING RUPTURE WAS ABOUT 160 PSI. AFTER THAT, THE BALLOON THAT WAS ON THE CONTRALATERAL SIDE WAS REINSERTED AND INFLATED. THE CONTRAST MEDIA INSIDE THE VERTEBRAL BODY WAS REMOVED FROM THE PATIENT BODY BY SUCTION, AND IT WAS CONFIRMED BY THE IMAGE THERE WAS NO CONTRAST MEDIA INSIDE THE VERTEBRAL BODY. THEN, CEMENT WAS FILLED AND THE OPERATION WAS COMPLETED. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9364761 ↗
• MalfunctionNov 13, 2019Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS BALLOON KYPHOPLASTY. INTRA-OP, THE BALLOON RUPTURED. AFTER THE FIRST BALLOON WAS PLACED IN THE VERTEBRAL BODY AND INFLATED, THE SURGEON ATTEMPTED TO PLACE THE SECOND BALLOON AS WELL. THE SECOND BALLOON COULD NOT BE INSERTED TO A SUFFICIENT DEPTH; SO, THE SURGEON PERFORMED DRILLING AGAIN TO THE CONTRALATERAL SIDE AND THEN PLACED THE BALLOON. AFTER THAT, WHEN THE SURGEON ATTEMPTED TO INFLATE THE BALLOON, IT WAS FOUND THAT CONTRAST MEDIUM HAD LEAKED FROM THE FIRST INFLATED BALLOON. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY BY USING A SUBSTITUTE PRODUCT. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIA. NO FRAGMENT OF THE RUPTURED BALLOON REMAINED INSIDE THE PATIENT. ALTHOUGH THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS THE RESULT OF THIS EVENT, NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9317395 ↗
• MalfunctionNov 13, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN SURGERY DUE TO MULTIPLE MYELOMA. INTRA-OP, THE BALLOON THAT WAS INSERTED TO THE RIGHT SIDE OF T12 BROKE AND CONTRAST MEDIA LEAKED. THE LEAKED CONTRAST MEDIA WAS WASHED WITH WATER AND WAS SUCKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME PRODUCT AND WITHOUT ANY DELAY. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9314105 ↗
• MalfunctionOct 27, 2019Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF PROCEDURE: COMPRESSION FRACTURE IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT L3. INTRA-OP, BALLOON RUPTURED DURING INFLATION. THE BALLOON RUPTURED WHEN IT CONTACTED THE BONE FRAGMENT THAT APPEARED TO HAVE BONE SCLEROSIS. WHEN LEAKAGE OF CONTRAST MEDIA WAS FOUND, BALLOON INFLATION WAS STOPPED AND WASHING WAS PERFORMED. THEN, CEMENT WAS INJECTED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIA. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9243343 ↗
• MalfunctionOct 27, 2019Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA-OP, AFTER BALLOON INFLATION, WHEN THE SURGEON PULLED THE HANDLE OF THE INFLATION SYRINGE TO DEFLATE THE BALLOON, THE BLOOD FLOWED BACK. THE BALLOON HAD RUPTURED. BONE QUALITY WAS HARD AND THE PRESSURE WAS CONSIDERABLE. THE PRESSURE AFTER INFLATION DID NOT REACH 400 PSI. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9243342 ↗
• MalfunctionOct 23, 2019Deflation Problem; Deflation Problem

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA OP, AFTER BALLOON INFLATION, WHEN THE SURGEON TRIED TO DEFLATE IT, IT COULD NOT BE DEFLATED EVEN WHEN THE HANDLE OF THE INFLATION SYRINGE WAS PULLED. THE BALLOON COULD STILL NOT BE DEFLATED WHEN THE SURGEON REMOVED THE INFLATION SYRINGE FROM THE INFLATABLE BONE TAMP (IBT). THEN THE LOCKING SYRINGE WAS ATTACHED TO THE IBT AND LOCKING SYRINGE WAS USED INSTEAD TO SUCK THE CONTRAST MEDIA, BUT THE BALLOON DID NOT DEFLATE. SO, THE BALLOON WAS REMOVED BY FORCE. IT IS SAID THAT THE BALLOON AMONG THE RETURNED ITEMS WAS IN A HALF INFLATED STATE. THE PROCEDURE WAS HOWEVER COMPLETED SUCCESSFULLY WITH THE SAME PRODUCT; AND NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT. IN THE SALES REP OPINION, PROBABLY THE PRODUCT WAS USED WITHOUT THE STYLET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9226700 ↗
• MalfunctionOct 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT L2. INTRA-OP, THE BALLOON OF THE RIGHT SIDE INFLATABLE BONE TAMP (IBT) RUPTURED FROM THE CAUDAL SIDE. THE BALLOON INFLATED LIKE THE SHAPE OF AN OBLONG CUT IN HALF ALTHOUGH IT WAS INFLATED FROM THE CENTER OF THE VERTEBRAL BODY. WHEN IT WAS CONSIDERED THAT THE BALLOON HAD INFLATED ENOUGH, THE SURGEON WENT TO PERFORM CEMENT MIXING. THE PRESSURE WAS ABOUT 160 PSI AT THAT TIME. DURING CEMENT MIXING, IT WAS NOTICED THAT THE PRESSURE HAD BECOME ZERO; HENCE, IMAGE CONFIRMATION WAS ASKED FOR. FROM THE SHAPE OF THE CONTRAST MEDIA IN THE CAPTURED IMAGE, IT WAS JUDGED THAT THE BALLOON RUPTURED. WITHOUT PERFORMING WASHING, THE HANDLE OF THE IBT SYRINGE WAS PULLED AND THE CONTRAST MEDIA WAS SUCKED. AS IT BECAME A LEVEL THAT WAS UNABLE TO BE DISCRIMINATED EVEN WITH THE IMAGES, THE CEMENT WAS FILLED AND THE OPERATION WAS FINISHED WITHOUT ANY FURTHER PROBLEM. NO FRAGMENT OF THE RUPTURED BALLOON REMAINED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9211694 ↗
• MalfunctionOct 10, 2019Inflation Problem; Inadequacy of Device Shape and/or Size; Material Deformation; Inflation Problem; Inadequacy of Device Shape and/or Size; Material Deformation

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA-OP, THE BALLOON DISTORTED ON INFLATION. ADDITIONALLY, THE POSITION OF THE MARKER DEVIATED; AND THUS, THE PRODUCT WAS TAKEN OUT OF THE PATIENT'S BODY. ON CHECKING, THE STYLET AND INNER TUBE INSIDE THE BALLOON APPEARED TO BE DEFORMED. THEREFORE, THE INFLATABLE BONE TAMP WAS REPLACED WITH ANOTHER ONE AFTER USING THE CURETTE. THE BONE QUALITY OF THE PATIENT SEEMED TO BE HARD; BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9176601 ↗
• InjuryOct 10, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY DUE TO OSTEOPOROTIC SPINAL FRACTURE OF T12 AND L1. INTRA-OP, THE LEFT INFLATABLE BONE TAMP (IBT) OF L1 INFLATED IN A VERTICAL SNOWMAN SHAPE THAT PUSHED UP THE SUPERIOR ENDPLATE. THEN, THE SURGEON DEFLATED IT AND WAITED FOR THE CONTRAST TO COME INTO THE INFLATION SYRINGE, BUT THE SURGEON STRUGGLED TO EXTRACT IT. IT WAS NOTED THAT THE WIRE CAME LOOSE AND PULLED AWAY FROM THE BACK OF THE BALLOON BUT WHEN HE TRIED TO PUSH IT FORWARD, IT WOULDN'T BUDGE. THEN SURGEON PULLED HARD AND THE IBT CAME OUT BUT THE SILICONE PIECE OF THE BALLOON WAS LEFT BEHIND IN THE PATIENT'S VERTEBRAL BODY. THE BALLOON RUPTURED DURING DEFLATION WHEN THE PRESSURE WAS LESS THAN 200 PSI AND VOLUME OF RUPTURE WAS 3 CC. THE SURGEON CEMENTED THE BROKEN FRAGMENT OF THE BALLOON IN PLACE. CEMENT WAS INJECTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9175746 ↗
• MalfunctionSep 22, 2019Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE TYPE OF PROCEDURE: BALLOON KYPHOPLASTY LEVELS IMPLANTED: TH11 IT WAS REPORTED THAT INTRA-OP, AS THE BALLOON INFLATED INTO AN OVAL SHAPE, A CURETTE WAS USED AFTER THE BALLOON WAS REMOVED. EVEN AFTER USING THE CURETTE, THE BALLOON DID NOT INFLATE PROPERLY, BUT IT WAS CONTINUED TO PREPARE THE BONE CEMENT. WHEN THE BALLOON WAS CONFIRMED BY THE IMAGE AT THE TIME OF CHECKING VISCOSITY OF THE CEMENT, A SHADOW AS IF SHOWING THAT THE CONTRAST MEDIUM HAD LEAKED WAS SEEN. SO, THE BALLOON WAS DEFLATED AND REMOVED. IT WAS ALSO CONFIRMED OUTSIDE THE OPERATIVE FIELD THAT THE BALLOON HAD RUPTURED. IT WAS DETERMINED THAT THE BALLOON RUPTURED AT HIGH PRESSURE. AFTER WASHING, THE SURGEON CONTINUED THE OPERATION. BONE CEMENT WAS FILLED IN THE CAVITY WHICH WAS CREATED AND THEN WOUND CLOSURE WAS PERFORMED. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. NO FRAGMENT OF THE RUPTURED BALLOON REMAINED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9101832 ↗
• MalfunctionSep 22, 2019Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE TYPE OF PROCEDURE: BALLOON KYPHOPLASTY LEVELS IMPLANTED: TH11 IT WAS REPORTED THAT INTRA-OP, AS THE BALLOON INFLATED INTO AN OVAL SHAPE, A CURETTE WAS USED AFTER THE BALLOON WAS REMOVED. EVEN AFTER USING THE CURETTE, THE BALLOON DID NOT INFLATE PROPERLY, BUT IT WAS CONTINUED TO PREPARE THE BONE CEMENT. WHEN THE BALLOON WAS CONFIRMED BY THE IMAGE AT THE TIME OF CHECKING VISCOSITY OF THE CEMENT, A SHADOW AS IF SHOWING THAT THE CONTRAST MEDIUM HAD LEAKED WAS SEEN. SO, THE BALLOON WAS DEFLATED AND REMOVED. IT WAS ALSO CONFIRMED OUTSIDE THE OPERATIVE FIELD THAT THE BALLOON HAD RUPTURED. IT WAS DETERMINED THAT THE BALLOON RUPTURED AT HIGH PRESSURE. AFTER WASHING, THE SURGEON CONTINUED THE OPERATION. BONE CEMENT WAS FILLED IN THE CAVITY WHICH WAS CREATED AND THEN WOUND CLOSURE WAS PERFORMED. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. NO FRAGMENT OF THE RUPTURED BALLOON REMAINED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9101827 ↗
• MalfunctionSep 1, 2019Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE LEVELS IMPLANTED: T12 IT WAS REPORTED THAT INTRA-OP, THE BALLOON RUPTURED DURING INFLATION. THE PROCEDURE WAS HOWEVER COMPLETED WITH THE SAME PRODUCT. IT IS UNKNOWN IF THERE WERE ANY PATIENT COMPLICATIONS DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8952935 ↗
• MalfunctionAug 8, 2019Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  PRE OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, WHILE INFLATING THE BALLOON IN THE VERTEBRAL BODY, LEAKAGE OF CONTRAST MEDIA WAS NOTED. WHEN THE PRODUCT WAS TAKEN OUT AND CHECKED, IT WAS FOUND THAT THERE WAS CUT/CRACK ON THE BALLOON. THE OPERATION WAS HOWEVER COMPLETED WITH THE SAME PRODUCT WITHOUT ANY FURTHER ISSUES. NO FRAGMENT OF THE RUPTURED BALLOON REMAIN INSIDE THE PATIENT. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA LEAK; AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8876167 ↗
• MalfunctionAug 8, 2019Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS BALLOON KYPHOPLASTY TO TREAT OSTEOPOROTIC VERTEBRAL FRACTURE. INTRA-OP, WHILE EXPANDING THE BALLOON IN THE VERTEBRAL BODY, IT WAS CONFIRMED THAT THE CONTRAST MEDIA LEAKED. WHEN THE INFLATABLE BONE TAMP WAS TAKEN OUT, A TEAR WAS OBSERVED ON THE BALLOON AT THE TIP. THE PROCEDURE WAS HOWEVER COMPLETED SUCCESSFULLY WITH THE SAME PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8875130 ↗
• MalfunctionAug 2, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN SURGERY AT T12 DUE TO PRIMARY OSTEOPOROSIS. INTRA-OP, THE BALLOON RUPTURED DURING INFLATION. THERE WAS A DELAY OF LESS THAN A 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO ANY FRAGMENT OF THE BALLOON REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT. UPDATE (B)(6) 2019: AFTER THE BALLOON WAS INFLATED, IT WAS BROKEN AFTER REMOVING THE STYLET. THE NEW ONE WAS NOT OPENED, AND THE REST ONE BALLOON WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8853885 ↗
• MalfunctionJul 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS BALLOON KYPHOPLASTY DUE TO COMPRESSION FRACTURE AT L3. INTRA-OP, AT THE TIME OF EXPANDING THE BALLOON, THE BALLOON DID NOT INFLATE AND CONTRAST MEDIA STARTED LEAKING OUT OF THE BALLOON. DAMAGES SUCH AS PIN HOLES COULD NOT BE IDENTIFIED ON THE BALLOON BY VISUAL CHECK. A NEW IBT WAS THEN UNPACKED AND WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8787400 ↗
• MalfunctionJul 5, 2019Inflation Problem; Inflation Problem

  PRE OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA-OP, THE BALLOON OF THE IBT (INFLATABLE BONE TAMP) DID NOT INFLATE EVENLY DURING INFLATION. THE BALLOON ONLY INFLATED IN ONE DIRECTION. THERE WAS ALSO A SITUATION THAT THE VERTEBRAL BODY WAS HARD. THE PROCEDURE WAS HOWEVER COMPLETED WITH THE SAME PRODUCT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8765514 ↗
• MalfunctionJul 1, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY DUE TO COMPRESSION FRACTURE. INTRA-OP, DURING INFLATION, THE BALLOON RUPTURED. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. REPORTEDLY, THE BALLOON EITHER HAD A HOLE FROM THE BEGINNING OR IT ENCOUNTERED WITH A SHARP BONE ON INSERTION. 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 8747135 ↗
• MalfunctionJun 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS VERTEBROPLASTY DUE TO COMPRESSION FRACTURE. INTRA-OP, DURING INFLATION, THE BALLOON RUPTURED AT THE END. THE PROCEDURE WAS COMPLETED BY USING A SUBSTITUTE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8690742 ↗
• MalfunctionJun 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE LEVELS IMPLANTED: L1 IT WAS REPORTED THAT INTRA-OP, THE CONTRAST MEDIA LEAKED FROM THE INSERTION PORT WHEN PULLING OUT THE STYLET DURING BALLOON INFLATION. THE STYLET WAS THEN REMOVED, AND THE OPERATION WAS CONTINUED. PRESSURE OF THE BALLOON PRIOR TO LEAKAGE WAS 200PSI AND VOLUME WAS 3ML. AS THERE WAS NO LEAKAGE OF THE CONTRAST MEDIA INTO THE PATIENT BODY AND THE CAVITY CREATION WAS FINISHED AS WELL, THE PHYSICIAN STARTED CEMENT INJECTION. NO FRAGMENT OF THE BALLOON REMAINED INSIDE THE PATIENT. THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS; AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8664678 ↗
• MalfunctionMay 6, 2019Leak/Splash; Leak/Splash

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, CONTRAST MEDIA LEAKED FROM THE IBT BALLOON. A NEW IBT WAS THEN USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIA; HENCE, THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8583320 ↗

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.