KYPHON Express II Inflatable Bone TampRecalls & reported problems across all models

We found 6 models of KYPHON Express II Inflatable Bone Tamp by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Jan 1, 2019 and Dec 1, 2025 — classified as 1 injury, 46 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (43 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 Inflatable Bone Tamp problems

KYPHON Express II Inflatable Bone Tamp models

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

• KYPHON Express II Inflatable Bone Tamp KE152

  Arthroscope
  22 reports
• KYPHON Express II Inflatable Bone Tamp KE152

  TAMP
  13 reports
• KYPHON Express II Inflatable Bone Tamp KE102

  TAMP
  3 reports
• KYPHON Express II Inflatable Bone Tamp KE202

  TAMP
  3 reports
• KYPHON® Express™ II Inflatable Bone Tamp KE102

  TAMP
  3 reports
• KYPHON Express II Inflatable Bone Tamp KE202

  Arthroscope
  3 reports

Recent KYPHON Express II Inflatable Bone Tamp adverse event reports

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

• MalfunctionDec 1, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY DUE TO T10 COMPRESSION FRACTURE (PRIMARY OSTEOPOROSIS). IT WAS REPORTED THAT THE IBTRUPTURED DURING EXPANSION (APPROXIMATELY 1.5 CC AT 300 PSI); THERE WAS NO RETAINED BALLOON FRAGMENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER CLEANING AND CEMENT FILL WITH FINAL INSTRUMENTATION, WITHOUT DELAY OR HOSPITALIZATION. THE PATIENT EXPERIENCED NO SYMPTOMS OR COMPLICATIONS AND RECOVERED WITH NO HEALTH DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677982 ↗
• MalfunctionOct 30, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING F ILLING CEMENT AS PART OF L2 BKP PROCEDURE IN A PATIENT DIAGNOSED WITH COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT IBT ONLY BULGED FROM THE INSERTION SITE TO THE HEAD. THE BALLOON RUPTURED AROUND THE UPPER END PLATE. AFTER THE BALLOON RUPTURE, THE IBT COULD NOT BE PULLED OUT FROM THE CANNULA OF THE OSTEO INTRODUCER, SO THE IBT STYLET WAS PULLED OUT AND THEN PULLED OUT, BUT HALF OF THE TIP OF THE BALLOON AND THE X-RAY MARKER WERE SEPARATED AND REMAINED IN THE BODY. THERE WAS A DELAY OF LESS THAN 60 MINS. THERE IS NO PLAN FOR AN ADDITIONAL PROCEDURE TO REMOVE THE BALLOON TIP WHICH IS IN PATIENT'S BODY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23424961 ↗
• MalfunctionSep 5, 2025Material Rupture; Material Rupture

  (B)(4) (REP, HCP, FOR): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L1 TRANSCUTANEOUS VERTEBROPLASTY PROCEDURE IN A PATIENT DIAGNOSED WITH COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. PATIENT MEDICAL HISTORY: HYPERTENSION, HYPERLIPIDEMIA, APPENDICITIS, CATARACT, CEREBRAL INFARCTION, BRONCHIAL ASTHMA. IT WAS REPORTED THAT WHEN THE BALLOON WAS INSERTED AND INFLATED, IT RUPTURED AT 310PSI. 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 22976503 ↗
• MalfunctionSep 5, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L3 BKP PROCEDURE IN A PATIENT DIAGNOSED WITH VERTEBRAL FRACTURE DUE TO OSTEOPOROSIS. IT WAS REPORTED THAT THE BALLOON RUPTURED WHEN THE L3 BALLOON WAS INFLATED AT 200PSI AT 2CC. 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 22976308 ↗
• MalfunctionJul 14, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A BKP PROCEDURE IN A PATIENT DIAGNOSED WITH COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT BREAKAGE WAS CONFIRMED DURING BALLOON INFLATION ON ONE SIDE, SO IT WAS REMOVED ONCE. BREAKAGE WAS CONFIRMED AGAIN WHEN THE USED BALLOON WAS USED ON THE CONTRALATERAL SIDE. WHEN THE BALLOON WAS INFLATED, IT WAS CONFIRMED THAT CONTRAST MEDIUM WAS LEAKING FROM THE BALLOON AT AROUND 200PSI, AND AFTER IT WAS REMOVED, A PINHOLE-SIZED HOLE WAS FOUND. THERE WAS A DELAY OF LESS THAN 60 MINS. 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 22492465 ↗
• MalfunctionJun 12, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A BONE TAMP KIT HAVING BALLOON KYPHOPLASTY (BKP) THERAPY. IT WAS REPORTED THAT BALLOON GOT DAMAGED AND RUPTURED DURING BKP SURGERY ON EXPANDING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192572 ↗
• MalfunctionJun 12, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE BALLOON RUPTURED WHEN THE PHYSICIAN WAS PULLING THE DEFLATED BALLOON OUT OF THE CANNULA. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191803 ↗
• MalfunctionJun 9, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A BKP PROCEDURE IN A PATIENT DIAGNOSED WITH COMPRESSION FRACTURE. THE RUPTURE OCCURRED DURING BALLOON EXPANSION. IT WAS REPORTED THAT DURING EXPANSION IBT RUPTURED. THE INCIDENT INVOLVED BALLOON DAMAGE (ON ONE SIDE) DURING EXPANSION. AFTER THE DAMAGE, THE BALLOON FROM THE OPPOSITE SIDE WAS INSERTED INTO THE DAMAGED SIDE AND EXPANDED AGAIN. THE OPERATION WAS COMPLETED WITHOUT ANY ISSUES. 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 22165360 ↗
• MalfunctionMay 27, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPLASTY FOR COMPRESSION FRACTURE. IT WAS REPORTED THAT DURING EXPANSION THE BALLOON WAS RUPTURED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT PRODUCT WAS USED ACCORDING TO IFU AND NOT DELIVERED AS DEFECTIVE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22086762 ↗
• MalfunctionMay 21, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L5 BALLOON KYPHOPLASTY DUE TO PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). IT WAS REPORTED THAT BALLOON RUPTURED DURING BALLOON INFLATION(L5 RIGHT) . 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 22058722 ↗
• MalfunctionMay 19, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS VE RTEBROPLASTY THERAPY FOR PRIMARY OSTEOPOROSIS WITH COMPRESSION FRACTURE. LEVELS IMPLANTED WAS 12. IT WAS REPORTED THAT THE BALLOON RUPTURED DURING EXPANSION. THE DOCTOR CONCLUDED THAT IT BURST UPON HITTING HARD BONE WITHIN THE VERTEBRAL BODY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE KE102 IS INCLUDED IN THE KEX102EB AND DISTRIBUTED IN JAPAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044523 ↗
• MalfunctionMay 16, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSCUTANEOUS VERTEBROPLASTY THERAPY FOR COMPRESSION FRACTURE. IT WAS REPORTED THAT DURING THE BKP PROCEDURE, A BALLOON BURST INSIDE THE VERTEBRAL BODY WHILE BEING INFLATED, RESULTING IN A TEAR. A NEW BALLOON WAS OPENED, AND IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES. 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 22032750 ↗
• MalfunctionMay 13, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY FOR L1 COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE BALLOON BROKE, RESULTING IN THE CONTRAST AGENT FLOWING OUT INTO THE VERTEBRAL BODY. THE IBT WAS WITHDRAWN AND THE CONTRAST MEDIUM INSIDE THE VERTEBRAL BODY WAS COLLECTED. 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 22007651 ↗
• MalfunctionMay 12, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSCUTANEOUS VERTEBROPLASTY (L1) DUE TO COMPRESSION FRACTURE (PRIMARY OSTEOPOROSIS). IT WAS REPORTED THAT  THE BALLOON WAS INFLATED DURING THE INITIAL INSERTION AND THEN CAREFULLY EXPANDED ONCE THE PRESSURE HAD DECREASED, BUT THE BALLOON BROKE/RUPTURED. PRE RUPTURE PRESSUE WAS 350 PSI. 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 22004005 ↗
• MalfunctionMay 12, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY. PRE-OP DIAGNOSIS OF PATIENT WAS COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT, THE BALLOON WAS RUPTURED DURING EXPANSION. THERE WERE NO FRAGMENTS OF RUPTURED BALLOON LEFT INSIDE THE PATIENT. NO TIME DELAY IN PROCEDURE REPORTED. THE LEVELS TREATED WERE UNKNOWN. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22000209 ↗

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