KYPHON Express II KyphoPak TrayRecalls & reported problems across all models

We found 3 models of KYPHON Express II KyphoPak Tray by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2019 and Nov 14, 2025 — classified as 2 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (28 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported KYPHON Express II KyphoPak Tray problems

KYPHON Express II KyphoPak Tray models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• KYPHON Express II KyphoPak Tray KEX152EB

  Arthroscope
  41 reports
• KYPHON Express II KyphoPak Tray KEX102EB

  Arthroscope
  14 reports
• KYPHON Express II KyphoPak Tray KEX202EB

  Arthroscope
  4 reports

Recent KYPHON Express II KyphoPak Tray adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Product Quality Problem; Material Deformation; Product Quality Problem; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY (L2) DUE TO PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). IT WAS REPORTED THAT THE CONNECTOR ON THE IBT SIDE AND THE CONNECTION TO THE BALLOON WERE DEFORMED. THE SAME THING HAPPENED WHEN BE WAS USED PREVIOUSLY, SO IT IS CONSIDERED A PROBLEM WITH THE QUALITY OF THE PRODUCT. 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 23551956 ↗
• MalfunctionAug 28, 2025Product Quality Problem; Mechanical Jam; Product Quality Problem; Mechanical Jam

  INFORMATION WAS RECEIVED VIA HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT HAVING TRANSCUTANEOUS VERTEBROPLASTY FOR TH11 COMPRESSION FRACTURE. IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE IBT STYLET, THERE IS A CREAKING SOUND AND IT WAS HARD THAT IT SEEMED LIKE IT COULD NOT BE ROTATED. THE PLIERS WERE TAKEN OUT AND ATTEMPTED TO REMOVE IT, BUT ONLY A PART COULD BE REMOVED AND THE STYLET COULD NOT BE REMOVED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910373 ↗
• MalfunctionJul 30, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT BALLOON BROKE. PROCEDURE INVOLVED WAS BALLOON KYPHO PLASTY. NO PATIENT SYMPTOMS DUE TO THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663212 ↗
• MalfunctionJun 3, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY WITH PERCUTANEOUS POSTERIOR FUSION THERAPY AT L1. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS PRIMARY OSTEOPOROSIS FOR RUPTURE FRACTURE. IT WAS REPORTED THAT DURING INITIAL INSERTION INTO THE VERTEBRAL BODY, THE BALLOON ON ONE SIDE WAS RUPTURED WHEN IT WAS INF LATED TO ABOUT 3 ML AFTER 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 22129670 ↗
• MalfunctionMay 20, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L1 BALLOON KYPH OPLASTY (BKP) FOR AN INDICATION OF PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE - INTRASPINE CLEFT). IT WAS REPORTED THAT THE BALLOON WAS DAMAGED (RUPTURED) DURING EXPANSION. 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 22050586 ↗
• MalfunctionMay 4, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED IN BALLOON KYPHOPLASTY (BKP) PROCEDURE USED FOR PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE IS COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BALLOON WAS DAMAGED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE BALLOON WAS RUPTURED WHICH OCCURRED DURING NORMAL USAGE OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21957436 ↗
• MalfunctionApr 3, 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 L3 RIGHT BALLOON WAS BROKEN, AND THE LEFT SIDE WAS ALSO FOUND TO BE BROKEN. RE-EXPAND WITH ADDITIONAL PRODUCT, BUT STILL, THE RIGHT SIDE WAS ALSO BROKEN. THERE WAS NO PROBLEM WITH THE LEFT SIDE. TYPE OF FRACTURE: COMPRESSION FRACTURE. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING A NEW PRODUCT. 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 BALLOON WAS BROKEN INSIDE THE PATIENT AND THEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760505 ↗
• MalfunctionApr 3, 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 L3 RIGHT BALLOON WAS BROKEN, AND THE LEFT SIDE WAS ALSO FOUND TO BE BROKEN. RE-EXPAND WITH ADDITIONAL PRODUCT, BUT STILL, THE RIGHT SIDE WAS ALSO BROKEN. THERE WAS NO PROBLEM WITH THE LEFT SIDE. TYPE OF FRACTURE: COMPRESSION FRACTURE. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING A NEW PRODUCT. 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 BALLOON WAS BROKEN INSIDE THE PATIENT AND THEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760465 ↗
• MalfunctionApr 1, 2025Difficult to Insert; Difficult to Insert

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS VE RTEBRAL BODY DEVELOPMENT BRIDGE FOR COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE INFLATABLE BALLOON TAMP COULD NOT BE INSERTED INTO THE OSTEO-INTRODUCER. A SEPARATE KIT WAS UNBOXED AND THEN INSERTED AND SURGERY WAS COMPLETED.  THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. 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 21736709 ↗
• MalfunctionMar 28, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING 3RD LUMBAR VERT EBRA TRANSCUTANEOUS VERTEBROPLASTY FOR AN INDICATION OF PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE: COMPRESSION FRACTURE, RUPTURE FRACTURE AND INTRASPINAL CLEFT. IT WAS REPORTED THAT THE IBT WAS RUPTURED WHILE INFLATING. 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 21716662 ↗
• 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 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED TRANSCUTANEOUS VERTEBROPLASTY THERAPY FOR THE PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE COMPRESSION, INTRASPINAL CLEFT. LEVELS IMPLANTED WERE L1. IT WAS REPORTED THAT FOLLOWING THE PROCEDURE MANUAL, AFTER PLACING BALLOONS ON BOTH SIDES, THE LEFT SIDE HAD A HIGH PRESSURE, BUT CAREFUL INFLATION ALLOWED FOR APPROXIMATELY 3CC OF EXPANSION WITHOUT ISSUES. ON THE RIGHT SIDE, THE PRESSURE INCREASED AFTER ABOUT 2CC OF FILLING. AS IT WAS SLOWLY ROTATED, THE PRESSURE SUDDENLY DROPPED FROM AROUND 300 TO A ZERO READING. THE FLUOROSCOPY VIDEO, THOUGH OBSCURED BY THE CONTRAST AGENT ON THE LEFT, CONFIRMED THAT THE RIGHT BALLOON HAD BURST, RELEASING CONTRAST AGENT. BOTH BALLOONS WERE IMMEDIATELY REMOVED, AND THE AREA WITHIN THE VERTEBRA WAS THOROUGHLY IRRIGATED MULTIPLE TIMES UNTIL THE CONTRAST AGENT WAS NO LONGER VISIBLE. SUBSEQUENTLY, BASED ON THE DOCTOR'S DECISION, CEMENT WAS FILLED, AND THE PROCEDURE CONCLUDED SUCCESSFULLY, APART FROM THE BALLOON RUPTURE. 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 21352603 ↗
• 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 17, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY (BKP) THERAPY FOR PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). LEVELS IMPLANTED AT L2. IT WAS REPORTED THAT WHEN THE BALLOON WAS INFLATED TO AROUND 3 CC (APPROXIMATELY 350 PSI), THE PSI DISPLAY BECAME 0; UPON CHECKING WITH THE ARM, IT WAS CONFIRMED THAT IT HAD CONTRACTED. THE RUPTURE OCCURRED DURING 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 21176410 ↗

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