Kyphon VuE Bone Cement and Kyphon Mixer CT01BRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000590970), received between Apr 16, 2024 and Mar 31, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING SPINAL THERAP Y. IT WAS REPORTED THAT WHILE MIXING CEMENT IT SOUNDED DIFFERENT THAN NORMAL AND WHEN PLUNGING IT DID NOT GO INTO THE CEMENT CARTRIDGES. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE WAS A KYPHOPLASTY. REP BELIEVED THAT IT WAS T7 OR T8 COMPRESSION FRACTURE. THE CEMENT WAS NOT HARD YET, IT WAS AFTER MIXING AND IT SHOULD¿VE OF BEEN THE TOOTHPASTE DRIP CONSISTENCY, BUT STILL MIXED VERY ODDLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24740082 ↗
• MalfunctionAug 1, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL REGARDING A PATIENT HAVING BALLOON KYPHOPLASTY FOR VERTEBRAL COMPRESSION FRACTURE OF T7 AND T8. IT WAS REPORTED THAT THE SCRUB MIXED THE CEMENT FOR APPROXIMATELY 1.5 MINUTES. FIRST CARTRIDGE: LEFT SIDE. INJECTED AFTER 10 MINUTES OF WORKING TIME. NO ISSUES WERE ENCOUNTERED DURING INJECTION. VISUALIZATION WAS ADEQUATE THROUGHOUT AND THE CEMENT DELIVERED APPROPRIATELY. SECOND CARTRIDGE: RIGHT SIDE. INJECTED AFTER 19 MINUTES OF WORKING TIME. CEMENT VISUALIZATION BECAME DIFFICULT ON FLUORO, PARTICULARLY ON THE RIGHT SIDE. EARLY IN THE INJECTION, CEMENT BEADS WERE VISIBLE DUE TO THE RUSE OF THE BFD. HOWEVER, ONCE THE SECOND CARTRIDGE WAS FULLY ENGAGED, THE CEMENT WAS HARDLY VISIBLE ON IMAGING. DESPITE LIMITED VISUALIZATION, A TOTAL OF 3.5 CC OF CEMENT WAS INJECTED FROM THE SECOND CARTRIDGE INTO THE RIGHT SIDE. THERE WAS CEMENT EXTRAVASATION. THERE WAS NO PATIENT SYMPTOM REPORTED AND NO PLAN OF HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Extravasation

  MAUDE report 22685253 ↗
• MalfunctionJul 22, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR VERTEBRAL COMPRESSION FRACTURE OF L1 WITH BIOPSY AND RADIOFREQUENCY ABLATION OF L1 FOR CANCER. IT WAS REPORTED THAT WHEN THE CEMENT INJECTION, THE RIGHT SIDE OF THE L1 VERTEBRAL BODY SHOWED APPROPRIATE CEMENT AND BARIUM PARTICLE VISUALIZATION ON AP AND LATERAL X-RAYS. HOWEVER, WHEN CEMENT WAS INJECTED ON THE LEFT SIDE, NEITHER CEMENT NOR BARIUM PARTICLES WERE VISUALIZED ON IMAGING, DESPITE 2.5CC BEING INJECTED. THIS RAISED CONCERNS FOR A POSSIBLE CEMENT LEAK, PARTICULARLY GIVEN THE INCREASED RISK OF CEMENT EXTRAVASATION IN THE PRESENCE OF A BONE TUMOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT, AND THERE WAS NO DELAY IN OVERALL PROCEDURE TIME OR NEED FOR ADDITIONAL SURGERY OR HOSPITALIZATION. AP AND LATERAL X-RAYS WERE TAKEN DURING THE PROCEDURE TO MONITOR CEMENT FILL. THE CEMENT WAS MIXED FOR 45 SECONDS, WAS DOUGHY AND HOMOGENOUS PRIOR TO DELIVERY, AND WAS STORED AT THE PROPER TEMPERATURE. THE EVENT WAS CONSIDERED RELATED TO THE USE OF THE PRODUCT. THERE WERE NO PATIENT SYMPTOMS AND COMPLICATIONS HAVE BEEN REPORTED AS A RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22562946 ↗
• InjuryMar 12, 2025Coagulation in Device or Device Ingredient; Product Quality Problem; Coagulation in Device or Device Ingredient; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR COMPRESSION FRACTURE. IT WAS REPORTED THAT DURING AN INTRA-OPERATIVE SPINAL PROCEDURE INVOLVING THE BONE CEMENT WITH MIXER, SEVERAL ISSUES AROSE WHEN REP WAS NOT IN THE EVENT. THE CEMENT WAS DESCRIBED AS RUNNY AND NOT DOUGHY AND HOMOGENOUS PRIOR TO DELIVERY, AND THE CEMENT GUN WAS LEAKING SALINE, PREVENTING THE ADVANCEMENT OF CEMENT INTO THE VERTEBRAL BODY. WHEN REP CAME BACK AND CHECKED THE ALLEGED DEVICES, IT LOOKED LIKE THE GUN WAS ADVANCING THE CEMENT, BUT THERE WASN'T ANY CEMENT IN THE PATIENT OR THE WEAPON. THIS LED TO THE ABANDONMENT OF THE CASE DUE TO PRODUCT FAILURE, AS THERE WAS NO BACKUP PRODUCT AVAILABLE. THE PROCEDURE WAS DELAYED, PROLONGING THE PATIENT'S EXISTING HOSPITALIZATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583845 ↗
• InjuryJul 16, 2024Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS COMPRESSION FRACTURE. IT WAS REPORTED THAT, CEMENT EXTRAVASATED BACK THROUGH POSTERIOR WALL BEHIND VERTEBRAL BODY. THE LEVELS IMPLANTED WERE T7. PROCEDURE OR TECHNIQUE PERFORMED WAS KYPHOPLASTY. AS A RESULT OF CEMENT EXTRAVASATION, PATIENT SUFFERED INCREASED PAIN AND AS AN ADDITIONAL PROCEDURE SURGERY WAS PERFORMED TO REMOVE 1 PEDICLE AND CLEAN OUT CEMENT DUE TO MINOR COMPRESSION ON CORD. PATIENT WAS HOSPITALIZED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Extravasation; Pain; Spinal Cord Injury

  MAUDE report 19748419 ↗
• MalfunctionApr 16, 2024Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE FOR OSTEOPOROTIC COMPRESSION FRACTURE OF SPINE T11. IT WAS REPORTED THAT CONSISTENCY OF THE CEMENT DID NOT SEEM APPROPRIATE AFTER MIXING. ONLY ONE OF THE CEMENT CARTRIDGES FILLED COMPLETELY. ONE CARTRIDGE FILLED ONLY HALF WAY. PRODUCT WAS NOT USED. NEW VUE CEMENT WAS OPENED MIXED AND IMPLANTED. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT PROCEDURE USED IN THIS EVENT WAS VERTEBRAL COMPRESSION FRACTURE BALLOON KYPHOPLASTY T11. 10 MINUTE DELAY HAPPENED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114553 ↗