KYPHON Xpander™ Inflatable Bone Tamp K09A (UDI 00763000311919)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00763000311919), received between Nov 22, 2021 and Dec 23, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY. IT WAS REPORTED THAT THE BALLOON HAS RUPTURED WHILE EXPANSION. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875861 ↗
• MalfunctionSep 16, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPLASTY DUE TO PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). IT WAS REPORTED THAT THE BALLOONWAS GRADUALLY INFLATED, AND WHEN THE 3 CC CONTRAST AGENT WAS REFILLED, THE BALLOON PRESSURE INCREASED TO 280 PSI. THE BALLOON RUPTURED WHILE WAITING FOR A WHILE, AND THE BALLOON PRESSURE DECREASED TO 0. THE BALLOON WAS REMOVED FROM THE DAMAGED IBT AND FILLED WITH CEMENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23061256 ↗
• MalfunctionSep 11, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED IN A PAT IENT HAVING SPINAL THERAPY AT LEVELS L1-4. PREOP DIAGNOSIS - VERTEBRAL FRACTURE. IT WAS REPORTED THAT AFTER INFLATION THE BALLOON RUPTURED AND THE CONTRAST MEDIUM LEAKED FROM THE VERTEBRAE. THE SURGERY WAS PERFORMED SUCCESSFULLY WITH THE OTHER (SECOND) BALLOON AND PROCEEDED WITHOUT COMPLICATIONS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025197 ↗
• MalfunctionAug 29, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS - COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BALLOON WAS RUPTURED DURING THE EXPANSION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920593 ↗
• MalfunctionJul 25, 2025Crack; Leak/Splash; Material Rupture; Crack; Leak/Splash; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY AT L3 FOR PRIMARY OSTEOPOROSIS WITH A COMPRESSION FRACTURE (INTRASPINAL CLEFT). IT WAS REPORTED THAT THE RIGHT BALLOON WAS CRACKED AND RUPTURED DURING EXPANSION. THE CONTRAST AGENT LEAKAGE WAS CONFIRMED WHEN IT WAS TRIED TO INFLATE TO 3.5 CC; THE PSI WAS ALSO 0; IT WAS DETERMINED THAT THE BALLOON HAD SPLIT. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610570 ↗
• MalfunctionJul 11, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3 BALLOON KYP HOPLASTY (BKP) FOR PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). IT WAS REPORTED THAT THE BALLOON RUPTURED WITHOUT TRIGGER DURING BALLOON INFLATION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477664 ↗
• MalfunctionMay 23, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR LAMINOPL ASTY SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS(COMPRESSION FRACTURE). LEVEL AT WHICH IMPLANT WAS PERFORMED IS L1. IT WAS REPORTED THAT THE BALLOON WAS RUPTURED WHEN THE BALLOON WAS INFLATED DURING THE INITIAL INSERTION. FLUSHED WITH SALINE, AND NO DEBRIS REMAINING IN THE BODY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076973 ↗
• MalfunctionMay 22, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY PROCEDURE (TH12) DUE TO PRIMARY OSTEOPOROSIS ( COMPRESSION FRACTURE). IT WAS REPORTED THAT AFTER INSERTION, EXPANSION AND VERIFICATION OF THE FRONT AND SIDE VIEWS WERE PERFORMED. WHILE THE BALLOON WAS EXPANDED INSIDE THE BODY, CEMENT MIXING WAS CONDUCTED. UPON CHECKING THE CEMENT VISCOSITY AND AT THE TIMING OF DEFLATING THE BALLOON, BLOOD BACKFLOW INTO ONE OF THE IBTS WAS OBSERVED, INDICATING BALLOON DAMAGE. THE OTHER IBT WAS USED WITHOUT ANY ISSUES. SINCE NO CONTRAST MEDIUM SHADOW WAS DETECTED ON THE IMAGE IN THE FULLY DEFLATED STATE, IT WAS ASSUMED THERE WERE NO RESIDUALS INSIDE THE BODY, AND THE PROCEDURE WAS CONTINUED. IT WAS NOTED THAT SIGNIFICANT BONE SCLEROSIS HAD PROGRESSED, AND ONLY 1.5CC OF CEMENT COULD BE FILLED AT A TIME, LEADING THE PHYSICIAN TO COMMENT THAT THE BONE MIGHT HAVE BEEN HARD. BALLOON RUPTURED DURING CONTRACTION. PRE- RUPTURE PRESSURE WAS NOT 200 PSI OR GREATER. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22068349 ↗
• MalfunctionJan 5, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER(HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL DEVICE USED FOR A PATIENT IN BALLOON KYPHOPLASTY(BKP). IT WAS REPORTED THAT DURING THE INFLATION PHASE, THE BALLOON SUDDENLY RUPTURED CAUSING CONTRAST MEDIUM TO SPREAD IN THE VERTEBRAL BODY. THE PRE-OPERATIVE DIAGNOSIS WAS MENTIONED AS T9 VERTEBRAL HEMANGIOMA. THERE WAS NO TIME DELAY IN PROCEDURE REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL TREATMENT OR SURGERY WAS PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Extravasation

  MAUDE report 16101020 ↗
• MalfunctionDec 2, 2022Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A IBT AND CURETTE USED IN A VERTE BROPLASTY FOR L3 COMPRESSION FRACTURE. IT WAS REPORTED THAT AN ATTEMPT COULD NOT BE MADE TO CHANGE THE ANGLE BY INSERTING THE CURETTE INTO THE BODY. THE WIRE OF CURETTE WAS BROKEN AND IT WAS DETERMINED THAT IT WAS DEFECTIVE, SO IT WAS REPLACED WITH A NEW PRODUCT. WHEN THE BALLOON WAS INSERTED AND INFLATED INTO THE RIGHT SIDE OF THE L3 VERTEBRAL BODY, IT WAS RUPTURED. PRODUCT GOT CONTAMINATED AND SO IT WAS DISPOSED OF PROPERLY IN THE HOSPITAL. IT WAS REPLACED WITH A NEW PRODUCT. SO THEIR WAS A DELAY IN PROCEDURE BY LESS THAN 60 MINS. THE OPERATION WAS COMPLETED SUCCESSFULLY. PREOPERATIVE DIAGNOSIS OF THIS SURGERY FOR THE PATIENT WAS PRIMARY OSTEOPOROSIS. THE PATIENT HAD BEEN SUFFERING FROM AN INFECTION, SO THE DEVICES HAVE BEEN DISCARDED. NO HEALTH DAMAGE CAUSED TO PATIENT DUE TO USAGE OF MDT PRODUCTS. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15902687 ↗
• MalfunctionSep 13, 2022Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR [PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. IT WAS REPORTED THAT THE IBT GOT BROKEN DURING INFLATION ON THE L5 VERTEBRAL BODY. A RUPTURE IN THE BALLOON WAS CONFIRMED AFTER THE CONTRAST AGENT WAS ASPIRATED AND CLEANED. AFTER INFLATING ON THE ANTERIOR VERTEBRAL BODY, INFLATION ON THE POSTERIOR PART WAS WANTED TO BE PERFORMED AS WELL SO THE POSITION OF THE BALLOON WAS MOVED AND INFLATION WAS PERFORMED. THE PHYSICIAN NOTICED THAT THE PRESSURE ON THE IBT HAD DECREASED, SO HE/SHE TOOK MEASURES TO DEAL WITH THE PROBLEM. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409066 ↗
• MalfunctionAug 25, 2022Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REP ORTED PRODUCT. THE PRE-OP DIAGNOSIS WAS MENTIONED AS PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. IT WAS REPORTED THAT AFTER THE BALLOON INFLATION, THE PRESSURE GAUGE BECOMES ZERO AND THE CONTRAST AGENT LEAKS DURING THE INSERTION AND REMOVAL OF THE STYLET. THE BALLOON WAS RUPTURED DURING INFLATION. THE LEVELS IMPLANTED WERE TWELFTH THORACIC VERTEBRAE. THE REPORTED BALLOON CAME IN CONTACT WITH PATIENT BODY. THERE WERE NO RUPTURED FRAGMENTS OF BALLOON LEFT INSIDE THE PATIENT BODY. THERE WAS NO TIME DELAY IN PROCEDURE REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15291810 ↗
• MalfunctionAug 4, 2022Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT USED IN KYPHOPL ASTY SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT WHEN THE BALLOON WAS INFLATED, THE PRESSURE DID NOT INCREASE EVEN WHEN THE HANDLE WAS TURNED; CONTRAST MEDIUM COULD NOT BE CONFIRMED TO HAVE ENTERED UNDER THE IMAGE AS THERE WAS A HOLE WHEN THE BALLOON WAS TOOK OUT OF SURGICAL FIELD AND TRIED TO INFLATE IT. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15162198 ↗
• MalfunctionJul 28, 2022Break; Leak/Splash; Break; Leak/Splash

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REP ORTED PRODUCT. THE PRE-OP DIAGNOSIS WAS MENTIONED AS COMPRESSION FRACTURE ¿ INTRASPINE CLEFT. IT WAS REPORTED THAT, THE BALLOON WAS INFLATED AND WAITED FOR THE PROPER VISCOSITY OF THE CEMENT. WHEN THE IMAGE WAS CHECKED TO REMOVE THE BALLOON BEFORE FILLING THE CEMENT, IT WAS BROKEN, AND THE CONTRAST AGENT SPREAD. THE PRESSURE WAS REDUCED A LITTLE BIT, SO IT WAS CONSIDERED TO HAVE BEEN BROKEN. THE BALLOON INFLATION METHOD WAS NOT A CLEAN ELLIPSE, BUT LIKE AN INFLATED PAIR OF WEIGHTS AND DENTED PARTS. IT WAS PRESUMED THAT THERE WAS A HARD BONE AND A LOAD WAS APPLIED TO IT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15119259 ↗
• MalfunctionMay 24, 2022Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT BALLOON KYPHOPLASTY (BKP) SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT RUPTURE WAS CONFIRMED AFTER INFLATION OF THE BALLOON. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT IT IS UNKNOWN IF THERE ARE ANY BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO REVISION SURGERY IS PLANNED OR SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14487019 ↗
• MalfunctionMay 6, 2022Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. THE PROCEDURE OR TECHNIQUE PERFORMED WAS BALLOON KYPHOPLASTY PROCEDURE. IT WAS REPORTED THAT, THE IBT WAS RUPTURED. IT WAS RUPTURED DURING EXPANSION. ONE SIDE OF THE IBT BECAME UNRESPONSIVE DURING THE CAVITY FORMATION, RESULTING IN A CLEAR LIQUID LEAK FROM THE OSTEO-INTRODUCER. THE CONTRAST AGENT LEAKED, CONTRAST MEDIUM WAS FLUSHED WITH SALINE AND HARDENED WITH CEMENT. THE BALLOON WAS LUMPED, SO THERE WERE PROBABLY NO DEBRIS. THERE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED BY USING THE SAME REPORTED IBT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14300214 ↗
• MalfunctionApr 26, 2022Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT BALLOON KYPHOPLASTY SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT WHEN THE BALLOON WAS INFLATING IN THE VERTEBRAL BODY IT WAS SUDDENLY RUPTURED. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE CONTRAST MEDIUM LEAKED AND IT WAS WASHED OUT. THERE ARE NO FRAGMENTS LEFT INSIDE THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14215692 ↗
• MalfunctionFeb 21, 2022Deflation Problem; Mechanical Problem; Deflation Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- PRIMARY OSTE OPOROSIS, COMPRESSION FRACTURE INVOLVED IN THE REPORTED EVENT. IT WAS REPORTED THAT INTRA-OPERATIVELY, IT WAS NOT SURE IF THE IBT WAS OUT OF ORDER. INFLATED ONE OF THE TWO BALLOONS IN THE VERTEBRAL BODY AND THEN DEFLATED IT, BUT AN EVENT OCCURRED THAT IT DID NOT DEFLATE. IT HAD BEEN REPORTED THAT ONE BALLOON WAS DEFLATED WITHOUT ANY PROBLEM, SO THEY USED THAT INFLATION SYRINGE TO CONNECT IT TO THE IBT THAT DID NOT DEFLATE AND PERFORMED THE DEFLATION OPERATION, BUT IT COULD NOT BE PULLED SMOOTHLY, AND IT SEEMS THAT IT WAS ABLE TO DEFLATE AFTER PERFORMING SEVERAL OPERATIONS. THEREFORE, THE TIME TO INSERT CEMENT WAS SHORTENED AND THE PLANNED AMOUNT OF CEMENT COULD NOT BE INSERTED DELAY IN OVERALL PROCEDURE TIME FOR LESS THAN 60 MINUTES. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. ON (B)(6) 2022, RECEIVED ADDITIONAL INFORMATION THAT THERAPY WAS BALLOON KYPHOPLASTY. THE BALLOON WAS ABLE TO INFLATE IN VERTEBRA WITHOUT ISSUES. LATER, IT COULD NO LONGER SHRINK. THERE WAS NO MALFUNCTION WITH THE CEMENT AND THE CAUSE OF THE ISSUE WAS THE BALLOON MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13567395 ↗
• MalfunctionFeb 15, 2022Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- PRIMARY OSTE OPOROSIS, BURST FRACTURE INVOLVED IN THE BALLOON KYPHOPLASTY PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE BALLOON DID NOT INFLATE. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR LESS THAN 60 MINUTES. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. LABELING WAS FOLLOWED THROUGHOUT THE PROCEDURE THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ON 2022-JAN-20, RECEIVED UPDATED INFORMATION THAT THE BALLOON ON ONE SIDE DID NOT INFLATE WHEN THE HANDLE WAS TURNED. THEREFORE, THEY OPENED A NEW ONE AND USED IT. EVEN THOUGH THE PRODUCT WAS REMOVED AND TRIED ON THE OUTSIDE OF THE SURGICAL FIELD, IT DID NOT INFLATE AS WELL. IN ADDITION, THERE WAS NO LEAKAGE OF CONTRAST MEDIA FROM THE BALLOON. THE BONE QUALITY WAS QUITE HARD. ON 2022-JAN-25, RECEIVED ADDITIONAL INFORMATION THAT THERE WAS ONLY MALFUNCTION WITH THE BALLOON. LEVELS TREATED FOR BACK PAIN. EVENT OCCURRED WHEN PRODUCT CAME IN CONTACT WITH PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13539486 ↗
• MalfunctionJan 19, 2022Leak/Splash; Material Puncture/Hole; Material Rupture; Leak/Splash; Material Puncture/Hole; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- PRIMARY OSTEOPOROSIS, COMPRESSION FRACTURE INVOLVED IN THE BALLOON KYPHOPLASTY PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, IBT RUPTURED DURING DEFLATION. THERE WERE NO FRAGMENTS OF THE RUPTURED BALLOON REMAINED IN THE PATIENT'S BODY. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PATIENT WAS NOT HOSPITALIZED PROLONG AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THERE WAS NO PROBLEM UNTIL THE SETTING, AND IT HAD BEEN NEGATIVE PRESSURE. THE BALLOON WAS INFLATED AND WAITED FOR CEMENT TO HARDEN. THE BALLOON WAS DEFLATED WHEN FILLING WITH CEMENT, AND WHEN THEY ATTEMPTED TO FILL THE CEMENT, THEY CONFIRMED A LEAK OF CONTRAST MEDIA. A SMALL HOLE WAS CONFIRMED WHEN IT WAS INFLATED AGAIN AFTER THE OPERATION, AND LEAKAGE OF CONTRAST MEDIA WAS CONFIRMED. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. ON 2022-JAN-08, RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO MALFUNCTION WITH THE ENTIRE PRODUCTS IN THE KIT. LEVELS CEMENT IMPLANTED- T12. NO CEMENT LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13287949 ↗
• MalfunctionNov 22, 2021Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING BKP FOR REGULAR OVF. THE PRE-OP DIAGNOSIS WAS MENTIONED AS PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. IT WAS REPORTED THAT, THE IBT WAS RUPTURED DURING INFLATION. THE PROCEDURE WAS PERFORMED SUCCESSFULLY BY USING THE REPORTED PRODUCT. THEY HAD CLEANED THOROUGHLY TO PREVENT THE RUPTURED FRAGMENTS FROM REMAINING, BUT IT IS NOT EXACTLY CLEAR. THERE WAS NO HEALTH DAMAGE IN PATIENT REPORTED. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS  A RESULT OF THIS EVENT. NO SYMPTOMS TO PATIENT OR PHYSICIAN REPORTED.  NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12850399 ↗

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-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-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.