KYPHON Express II KyphoPak Tray KEX102EBRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000026882), received between Aug 17, 2021 and Mar 12, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2025Material Rupture; Material Rupture

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. THE PATIENT WAS HAVING TRANSPEDICULAR T12 AND L1 KYPHOPLASTY FOR AN INDICATION OF AGE RELATED OSTEOPOROSIS WITH PATHOLOGICAL WEDGE FRACTURE OF T12, L1 VERTEBRAE. BALLOON RUPTURED AFTER REACHING 1.5CC INFLATION AND 390PSI. 3.0 ML/2.4ML BONE CEMENT INJECTED INSIDE VERTEBRAL BODIES. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21581843 ↗
• MalfunctionFeb 18, 2025Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS VERTEBROPLASTY (PVP) FOR AN INDICATION OF PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). IT WAS REPORTED THAT WHILE CONFIRMING THE CONDITION OF THE EXPANDED BALLOON UNDER FRONTAL FLUOROSCOPY, AN ATTEMPT WAS MADE TO REMOVE THE STYLET, BUT IT COULD NOT BE REMOVED. THE STYLET ON THE RIGHT SIDE GOT STUCK. WHEN INFLATING THE BALLOON, IT WAS PULLED FORWARD, SO IT WAS INFLATED ONCE, DEFLATED, AND THEN INFLATED AGAIN. THE LEFT SIDE WAS INFLATED NORMALLY. ALTHOUGH THE LEFT SIDE WAS TIGHT, THE STYLET WAS SOMEHOW REMOVED. THE RIGHT SIDE COULD NOT BE REMOVED, AND THE BALLOON WAS DEFLATED TO REMOVE IT ENTIRELY. AFTER REMOVAL, THE STYLET WAS PULLED AND FOUND TO BE BENT. 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 21393761 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSCUTANEOUS VERTEBROPLASTY (L5) FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE IBT DID NOT FIT SMOOTHLY INTO THE OSTEO INTRODUCER OUTER CASING, AND WHEN THE IBT WAS INSERTED WITH FORCE, THE IBT BROKE OFF. IBT GOT BENT DURING INITIAL INSERTION. THERE WAS NO SYMPTOM REPORTED. THE PROCEDURE WAS COMPLETED WITH NEW PRODUCT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301847 ↗
• MalfunctionJan 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE BALLOON WAS FOUND TO BE BROKEN WHEN THE BALLOON WAS INFLATED AT 3CC. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE CONTRAST AGENT LEAKED INTO THE VERTEBRAL BODY, BUT IT WAS SUCTIONED AND REMOVED. NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078644 ↗
• MalfunctionJan 4, 2025Break; Leak/Splash; Break; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE BALLOON KYPHOPLASTY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE BALLOON ON THE RIGHT SIDE OF TH12 WAS BROKEN. LEAKAGE OF THE CONTRAST MEDIUM WAS OBSERVED. NO PATIENT SYMPTOMS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074909 ↗
• MalfunctionJan 1, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T12 BKP FOR AN INDICATION OF PRIMARY OSTEOPOROSIS WITH COMPRESSION FRACTURE. IT WAS REPORTED THAT THE INFLATABLE BONE TAMP BROKE DURING BALLOON INFLATION. THERE WAS A DELAY OF LESS THAN 60 MINS REPORTED. 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 21050937 ↗
• MalfunctionNov 14, 2024Difficult to Insert; Product Quality Problem; Difficult to Insert; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING BKP- BALLOON KYPHOPLASTY FOR LUMBAR VERTEBRAL COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BALLOON DID NOT ENTER THROUGH THE INTRODUCER. THE OPPOSITE SIDE WAS ALSO TESTED, BUT IN THE SAME MANNER, T HERE WAS A STRONG CATCH AT THE NARROWING PART OF THE OSTER INTRODUCER AND DID NOT PROCEED. THE STYLET AND THE DRILL WERE ABLE TO BE OPERATED WITHOUT ANY PROBLEMS WITH THE OPERATING INTRODUCER. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. (B)(4)): ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE EVENT IS AN INITIAL DEFECT WHICH CONCLUDES THAT THE DEVICE HAVE MANUFACTURING ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20681625 ↗
• MalfunctionNov 6, 2024Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3 BKP FOR AN I NDICATION OF PRIMARY OSTEOPOROSIS COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BE BALLOON WAS RUPTURED. THE CEMENT WAS MIXED WITH THE 3CC BALLOON INFLATED AND WHEN THE VISCOSITY BECAME APPROPRIATE AND DEFLATION WAS PERFORMED, IT WAS DISCOVERED THAT A CONTRAST AGENT MIXED WITH BLOOD HAD RETURNED TO THE SYRINGE. A NEW KIT WAS OPENED AGAIN AND THE BALLOON WAS INFLATED TO CHECK THE CAVITY. THE CEMENT HAD ALREADY SOLIDIFIED, SO AN ADDITIONAL SET WAS OPENED WITH THE MIXER. THERE WAS A DELAY OF LESS THAN 60 MINS REPORTED. 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 20618406 ↗
• MalfunctionSep 17, 2024Difficult to Insert; Product Quality Problem; Mechanical Jam; Difficult to Insert; Product Quality Problem; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSCUTANEOUS VERTEBROPLASTY SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE BALLOON WAS NOT ADVANCING WELL, SO IT WAS REMOVED ONCE; WHEN AN ATTEMPT WAS MADE TO REINSERT IT AFTER THE DRILL, THE BALLOON GOT STUCK IN THE OSTEOINTRODUCER AND COULD NOT BE INSERTED INTO THE VERTEBRAL BODY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT IT WAS DISTORTED DUE TO THE WEAK CORE OF THE BALLOON WHEN THE LOAD WAS PUT THE BALLOON INSERTED INTO THE VERTEBRAL BODY AFTER THE DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236733 ↗
• MalfunctionJun 14, 2024Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING 2 VERTEBRAL BAL LOON KYPHOPLASTY(BKP) AT THE LEVEL TH11 - L2. IT WAS REPORTED THAT THE BALLOON WAS RUPTURED WHEN INFLATED AND BROKE DURING THE CEMENT MIXING. REMOVED AND FILLED WITH CEMENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE: COMPRESSION FRACTURE, INTRASPINE CLEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19535924 ↗
• MalfunctionJun 14, 2024Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING VERTEBRAL BKP FOR PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE WAS COMPRESSION FRACTURE, INTRASPINE CLEFT. IT WAS REPORTED THAT THE BALLOON WAS RUPTURED.  AFTER THE INSERTION WAS PLACED, IT WAS DAMAGED DURING THE INITIAL EXPANSION PERIOD. DAMAGE TO THE CONTRALATERAL SIDE CONTINUED DURING EXPANSION. ACCESSED WITH NEEDLE, THEN DRILLED. INFLATED AFTER BALLOON PLACEMENT. DAMAGED DURING EXPANSION. THE CONTRALATERAL SIDE WAS ALSO DAMAGED. A NEW KIT WAS UNPACKED AND HANDLED. AT THAT TIME, A CURETTE WAS USED AND REINSERTED THE IBT, BUT IT DID NOT GO IN. LEVEL AT WHICH THE IMPLANT WAS PERFORMED L3. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THERE WAS A DELAY IN THE OVERALL PROCEDURE TIME OF LESS THAN 60 MINUTES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT WHEN A NEW KIT WAS OPENED AND USED, AND THE IBT WAS REINSERTED USING A CURETTE, BUT IT DID NOT GO IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19535853 ↗
• MalfunctionMay 17, 2024Difficult to Insert; Product Quality Problem; Difficult to Insert; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE BALLOON WAS VERY HARD TO PUSH OUT OF THE TROCAR AND IT HAPPENED WITH BOTH BALLOONS. IT WAS NOT A NORMAL AMOUNT OF PRESSURE THAT THE SURGEON HAD TO APPLY TO GET THE BALLOON INTO THE VERTEBRAL BODY. SURGEON DRILLED MULTIPLE TIMES TO CREATE A SPACE FOR THE BALLOON, AND THE AIR WAS REMOVED FROM THE BALLOON PRIOR TO PUSHING IT DOWN THE TROCAR. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS KYPHOPLASTY AND LEVEL IMPLANTED WAS L1. THE DELAY IN SURGERY TIME WAS UNDER 60 MINUTES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340692 ↗
• MalfunctionMar 21, 2024Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPLASTY FOR METASTATIC SPINAL TUMOR AT T9. IT WAS REPORTED THAT AFTER BALLOON INFLATION, THE BALLOON WAS DAMAGED WHILE MAINTAINING VERTEBRAL BODY HEIGHT, AND CONTRAST MEDIUM LEAKED INTO THE VERTEBRAL BODY. AFTER RUPTURE, IT WAS REMOVED AS IT WAS, CLEANED, AND CEMENTED INTO THE VERTEBRAL 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 18947903 ↗
• MalfunctionAug 17, 2021Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY DUE TO OSTEOPOROTIC COMPRESSION FX OF L1. IT WAS REPORTED THAT BALLOON RUPTURED WITHIN NORMAL OPERATING CONDITIONS. THE OPERATOR ATTEMPTED TO PULL THE BALLOON OUT, BUT IT WOULD NOT PULL THROUGH CANNULA. THE WHOLE UNIT NEEDED TO BE REMOVED TOGETHER. 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 12329488 ↗