KYPHON Xpede Bone Cement and KYPHON Mixer PackRecalls & reported problems across all models

We found 2 models of KYPHON Xpede Bone Cement and KYPHON Mixer Pack by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Jan 12, 2017 and Sep 2, 2026 — classified as 3 deaths, 11 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (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 Xpede Bone Cement and KYPHON Mixer Pack problems

KYPHON Xpede Bone Cement and KYPHON Mixer Pack models

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

• KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack CX01B

  CEMENT, BONE, VERTEBROPLASTY
  3 deaths67 reports
• KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack CX01B

  CEMENT, BONE, VERTEBROPLASTY
  4 reports

Recent KYPHON Xpede Bone Cement and KYPHON Mixer Pack adverse event reports

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

• MalfunctionSep 2, 2026Coagulation in Device or Device Ingredient

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50557700 ↗
• MalfunctionApr 21, 2026Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T9 KYPHOPLASTY SPINAL THERAPY FOR T9 KYPHO WITH T9/10 INTERBODY FUSION. IT WAS REPORTED THAT THE BONE CEMENT WITH MIXER, TRANSPEDICULAR ACCESS WAS OBTAINED INTO THE T9 VERTEBRAL BODY, DRILLING WAS PERFORMED TO THE ANTERIOR LINE, A BALLOON WAS USED TO CREATE A CAVITY, AND CEMENT WAS DELIVERED USING 8-GAUGE BONE FILLERS. CEMENT EXTRAVASATION WAS DETECTED INTRA-OPERATIVELY, WITH CEMENT REPORTED IN THE SPINAL CANAL SPACE FROM MID T8 TO THE TOP OF T10, AND O-ARM SPINE IMAGING CONFIRMED CEMENT IN THE T8¿T10 CANAL SPACE. THERE WAS CONCERN FOR POTENTIAL PRESSURE ON NEURAL ELEMENTS FROM THE CANAL CEMENT, AND A LAMINECTOMY WAS PERFORMED TO RELIEVE POTENTIAL PRESSURE. A DELAY IN OVERALL PROCEDURE TIME WAS REPORTED. THE PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT, AND CEMENT REMAINED AT T9. THE CEMENT WAS REPORTED AS USED IN THE PATIENT, STORED AT PROPER TEMPERATURES, MIXED FOR 30 SECONDS, AND DOUGHY AND HOMOGENOUS PRIOR TO DELIVERY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED

  Patient problems: Extravasation

  MAUDE report 24935469 ↗
• MalfunctionApr 20, 2026Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR FUSION WITH FENESTRATED SCREWS/BONE CEMENT. IT WAS REPORTED THAT THE XPEDE CEMENT WAS MIXED FOR 30 SECONDS AND APPROX 4-5 MINUTES LATER THE SAMPLE, PRIMED IN THE BFD FILLER NEEDLES HAD HARDENED AND WAS UN-USABLE. 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 24926067 ↗
• MalfunctionMar 17, 2026Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A BONE CEMENT USED FOR SPINAL TH ERAPY. IT WAS REPORTED THAT CEMENT WAS BEING MIXED BUT INSTANTLY CURED BEFORE IT COULD ENTER THE CARTRIDGES. THE CARTRIDGES THAT COME IN THE KIT WERE UTILIZED WITH CEMENT AND THE CEMENT WOULD NOT FILL INTO THE CARTRIDGES. 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 24616098 ↗
• MalfunctionMar 17, 2026Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A BONE CEMENT USED FOR SPINAL TH ERAPY. IT WAS REPORTED THAT CEMENT WAS BEING MIXED BUT INSTANTLY CURED BEFORE IT COULD ENTER THE CARTRIDGES. THE CARTRIDGES THAT COME IN THE KIT WERE UTILIZED WITH CEMENT AND THE CEMENT WOULD NOT FILL INTO THE CARTRIDGES. 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 24616090 ↗
• MalfunctionDec 26, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A BONE CEMENT USED ON PATIENT HAVING T12 KYPHOPLASTY THERAPY FOR VERTEBRAL COMPRESSION FRACTURE (VCF). IT WAS REPORTED THAT THE BONE CEMENT WAS DESCRIBED AS TOO VISCOUS AND WAS NOT DOUGHY OR HOMOGENOUS PRIOR TO DELIVERY. BKP CEMENT HARDENING TOO QUICKLY, THREE DIFFERENT XPEDE CEMENT FAILED AND THE CEMENT YIELD WAS LOWER THAN EXPECTED, WITH ONLY 1.5-2CC OBTAINED INSTEAD OF THE ANTICIPATED 3-4CC. ALL THREE CEMENT FAILED DURING THE SAME PROCEDURE. ONLY 1CC WAS ABLE TO GET FROM THE SECOND XPEDE AND 1CC FROM THE THIRD XPEDE IN THE BONE FILLER AND INTO THE VERTEBRAL BODY. THE CEMENT WAS TOO VISCOUS TO GET INTO THE CDS SYSTEM. HENCE, PHYSICIAN WAS NOT ABLE USE THE CDS SYSTEM. THE CEMENT HAD BEEN MIXED FOR 20-30 SECONDS AND STORED AT THE PROPER TEMPERATURE AS PER LABELING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. PATIENT HAD BELOW EXPECTED PAIN RELIEF. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895478 ↗
• MalfunctionDec 26, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A BONE CEMENT USED ON PATIENT HA VING T12 KYPHOPLASTY THERAPY FOR VERTEBRAL COMPRESSION FRACTURE (VCF). IT WAS REPORTED THAT THE BONE CEMENT WAS DESCRIBED AS TOO VISCOUS AND WAS NOT DOUGHY OR HOMOGENOUS PRIOR TO DELIVERY. BKP CEMENT HARDENING TOO QUICKLY, THREE DIFFERENT XPEDE CEMENT FAILED AND THE CEMENT YIELD WAS LOWER THAN EXPECTED, WITH ONLY 1.5-2CC OBTAINED INSTEAD OF THE ANTICIPATED 3-4CC. ALL THREE CEMENT FAILED DURING THE SAME PROCEDURE. ONLY 1CC WAS ABLE TO GET FROM THE SECOND XPEDE AND 1CC FROM THE THIRD XPEDE IN THE BONE FILLER AND INTO THE VERTEBRAL BODY. THE CEMENT WAS TOO VISCOUS TO GET INTO THE CDS SYSTEM. HENCE, PHYSICIAN WAS NOT ABLE USE THE CDS SYSTEM. THE CEMENT HAD BEEN MIXED FOR 20-30 SECONDS AND STORED AT THE PROPER TEMPERATURE AS PER LABELING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. PATIENT HAD BELOW EXPECTED PAIN RELIEF. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895451 ↗
• MalfunctionDec 26, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A BONE CEMENT USED ON PATIENT HAVING T12 KYPHOPLASTY THERAPY FOR VERTEBRAL COMPRESSION FRACTURE (VCF). IT WAS REPORTED THAT THE BONE CEMENT WAS DESCRIBED AS TOO VISCOUS AND WAS NOT DOUGHY OR HOMOGENOUS PRIOR TO DELIVERY. BKP CEMENT HARDENING TOO QUICKLY, THREE DIFFERENT XPEDE CEMENT FAILED AND THE CEMENT YIELD WAS LOWER THAN EXPECTED, WITH ONLY 1.5-2CC OBTAINED INSTEAD OF THE ANTICIPATED 3-4CC. ALL THREE CEMENT FAILED DURING THE SAME PROCEDURE. ONLY 1CC WAS ABLE TO GET FROM THE SECOND XPEDE AND 1CC FROM THE THIRD XPEDE IN THE BONE FILLER AND INTO THE VERTEBRAL BODY. THE CEMENT WAS TOO VISCOUS TO GET INTO THE CDS SYSTEM. HENCE, PHYSICIAN WAS NOT ABLE USE THE CDS SYSTEM. THE CEMENT HAD BEEN MIXED FOR 20-30 SECONDS AND STORED AT THE PROPER TEMPERATURE AS PER LABELING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. PATIENT HAD BELOW EXPECTED PAIN RELIEF. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895434 ↗
• MalfunctionOct 17, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING VERTEBROPLASTY. IT WAS REPORTED THAT THE CEMENT HARDENED FASTER THAN EXPECTED, APPROXIMATELY 1 MINUTE AFTER MIXING IT WAS DIFFICULT TO TRANSFER INTO A CDS CARTRIDGE, BUT WAS JUST ABLE TO USE THE CARTRIDGE. SURGEON THEN ATTEMPTED TO FILL A SECOND CARTRIDGE AND THE CEMENT HAD COMPLETELY HARDENED. A SECOND BOX OF CEMENT WAS OPENED AND THE CEMENT WAS AGAIN UNABLE TO BE TRANSFERRED INTO THE CARTRIDGE. THERE WAS AT LEAST A 10 MINUTE DELAY IN THE OVERALL PROCEDURE. 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 23321637 ↗
• MalfunctionOct 17, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING VERTEBROPLASTY. IT WAS REPORTED THAT THE CEMENT HARDENED FASTER THAN EXPECTED, APPROXIMATELY 1 MINUTE AFTER MIXING IT WAS DIFFICULT TO TRANSFER INTO A CDS CARTRIDGE BUT WAS JUST ABLE TO USE THE CARTRIDGE. SURGEON THEN ATTEMPTED TO FILL A SECOND CARTRIDGE AND THE CEMENT HAD COMPLETELY HARDENED. A SECOND BOX OF CEMENT WAS OPENED AND THE CEMENT WAS AGAIN UNABLE TO BE TRANSFERRED INTO THE CARTRIDGE. THERE WAS AT LEAST A 10 MINUTE DELAY IN THE OVERALL PROCEDURE. 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 23321618 ↗
• MalfunctionOct 16, 2025Coagulation in Device or Device Ingredient; Product Quality Problem; Coagulation in Device or Device Ingredient; Product Quality Problem

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE STATING THE REPORTED ITEM WAS DISCARDED BY CUSTOMER AS IT WAS USED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308342 ↗
• MalfunctionSep 5, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT UPON POURING THE LIQUID MONOMER INTO THE MIXER, IT DID NOT REMAIN CONTAINED WITHIN THE MIXING BODY AND INSTEAD LEAKED ONTO THE TABLE. 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 22976054 ↗
• MalfunctionJul 18, 2025Coagulation in Device or Device Ingredient; Use of Device Problem; Coagulation in Device or Device Ingredient; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A KYPHON AND HVR BONE CEMENT WITH MIXER HAVING SPINAL THERAPY. IT WAS REPORTED THAT PROCEDURE STARTED OUT NORMAL WITH ACCESS VIA PEDICLES INTO VERTEBRAE AND THEN OSTEOCOOL WAS PERFORMED ON LEVELS T5 AND T11. ONCE THE OSTEOCOOL WAS DONE, THE KYPHOPLASTY WITH BALLOONS WAS PERFORMED WITHOUT ANY ISSUES. THERE WAS DIFFICULTY MIXING THE BONE CEMENT DUE TO LACK OF FAMILIARITY WITH THE EQUIPMENT. WHEN ADMINISTERING THE XPEDE INTO THE BFDS, THE CEMENT WASN'T COMING OUT AND WITHIN ABOUT 1 MINUTE OF IT BEING MIXED IT HARDENED IN THE BONE FILLER AND THE MIXER WITH PLUNGER. A SECOND XPEDE KIT WAS OPENED WHEN THIS HAPPENED AND ENDED WITH THE SAME RESULT, WHICH AT THAT POINT A THIRD XPEDE KIT WAS OPENED WITH MIXER AND WITHIN A MINUTE OF MIXING IT, THE CEMENT HAD HARDENED AND THE SCRUB TECH BROKE THE TOP OF THE MIXER OFF. ADDITIONALLY, THE HVR BONE CEMENT WAS UNABLE TO BE DELIVERED BECAUSE IT WAS TOO WARM TO WORK WITH UPON ARRIVAL IN THE IR ROOM. MULTIPLE CEMENT MIXER KITS (FOUR) WERE RENDERED UNUSABLE DURING THE PROCEDURE. THE CASE WAS COMPLETED USING AN ALTERNATIVE PRODUCT FROM ANOTHER MANUFACTURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540147 ↗
• MalfunctionJul 18, 2025Coagulation in Device or Device Ingredient; Use of Device Problem; Coagulation in Device or Device Ingredient; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A KYPHON AND HVR BONE CEMENT WITH MIXER HAVING SPINAL THERAPY. IT WAS REPORTED THAT PROCEDURE STARTED OUT NORMAL WITH ACCESS VIA PEDICLES INTO VERTEBRAE AND THEN OSTEOCOOL WAS PERFORMED ON LEVELS T5 AND T11. ONCE THE OSTEOCOOL WAS DONE, THE KYPHOPLASTY WITH BALLOONS WAS PERFORMED WITHOUT ANY ISSUES. THERE WAS DIFFICULTY MIXING THE BONE CEMENT DUE TO LACK OF FAMILIARITY WITH THE EQUIPMENT. WHEN ADMINISTERING THE XPEDE INTO THE BFDS, THE CEMENT WASN'T COMING OUT AND WITHIN ABOUT 1 MINUTE OF IT BEING MIXED IT HARDENED IN THE BONE FILLER AND THE MIXER WITH PLUNGER. A SECOND XPEDE KIT WAS OPENED WHEN THIS HAPPENED AND ENDED WITH THE SAME RESULT, WHICH AT THAT POINT A THIRD XPEDE KIT WAS OPENED WITH MIXER AND WITHIN A MINUTE OF MIXING IT, THE CEMENT HAD HARDENED AND THE SCRUB TECH BROKE THE TOP OF THE MIXER OFF. ADDITIONALLY, THE HVR BONE CEMENT WAS UNABLE TO BE DELIVERED BECAUSE IT WAS TOO WARM TO WORK WITH UPON ARRIVAL IN THE IR ROOM. MULTIPLE CEMENT MIXER KITS (FOUR) WERE RENDERED UNUSABLE DURING THE PROCEDURE. THE CASE WAS COMPLETED USING AN ALTERNATIVE PRODUCT FROM ANOTHER MANUFACTURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540132 ↗
• MalfunctionJul 18, 2025Coagulation in Device or Device Ingredient; Use of Device Problem; Coagulation in Device or Device Ingredient; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A KYPHON AND HVR BONE CEMENT WITH MIXER HAVING SPINAL THERAPY. IT WAS REPORTED THAT PROCEDURE STARTED OUT NORMAL WITH ACCESS VIA PEDICLES INTO VERTEBRAE AND THEN OSTEOCOOL WAS PERFORMED ON LEVELS T5 AND T11. ONCE THE OSTEOCOOL WAS DONE, THE KYPHOPLASTY WITH BALLOONS WAS PERFORMED WITHOUT ANY ISSUES. THERE WAS DIFFICULTY MIXING THE BONE CEMENT DUE TO LACK OF FAMILIARITY WITH THE EQUIPMENT. WHEN ADMINISTERING THE XPEDE INTO THE BFDS, THE CEMENT WASN'T COMING OUT AND WITHIN ABOUT 1 MINUTE OF IT BEING MIXED IT HARDENED IN THE BONE FILLER AND THE MIXER WITH PLUNGER. A SECOND XPEDE KIT WAS OPENED WHEN THIS HAPPENED AND ENDED WITH THE SAME RESULT, WHICH AT THAT POINT A THIRD XPEDE KIT WAS OPENED WITH MIXER AND WITHIN A MINUTE OF MIXING IT, THE CEMENT HAD HARDENED AND THE SCRUB TECH BROKE THE TOP OF THE MIXER OFF. ADDITIONALLY, THE HVR BONE CEMENT WAS UNABLE TO BE DELIVERED BECAUSE IT WAS TOO WARM TO WORK WITH UPON ARRIVAL IN THE IR ROOM. MULTIPLE CEMENT MIXER KITS (FOUR) WERE RENDERED UNUSABLE DURING THE PROCEDURE. THE CASE WAS COMPLETED USING AN ALTERNATIVE PRODUCT FROM ANOTHER MANUFACTURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540123 ↗

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