KYPHON® HV-R® Bone Cement and KYPHON® Mixer Pack C01B (UDI 00643169097834)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169097834), received between Oct 30, 2018 and Oct 23, 2025 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 reports).

2 other recalls cover devices cleared under the same FDA submission (K041584); they may or may not involve this specific model.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY FOR AN INDICATION OF OSTEOPOROSIS FRACTURE OF T5/T6. IT WAS REPORTED THAT THE DOCTOR ACCESSED THE LEFT SIDE OF THE PEDICLE OF T5 AND T6, PERFORMED BIOPSIES, AND BALLOONED BOTH VERTEBRAL BODIES. CEMENT WAS INJECTED AT T6, AND IT WAS OBSERVED THAT THE CEMENT APPEARED TO APPROACH THE NEURAL FORAMEN. AT T5, THE BALLOON WAS FOUND TO STILL BE INFLATED AS CEMENT INJECTION BEGAN, AND THE CEMENT APPEARED TO BE IN THE NEURAL FORAMEN. THE PROCEDURE WAS CONCLUDED AFTER THE DOCTOR PULLED BOTH TROCARS AND TOOK A FINAL IMAGE. THE PATIENT REPORTEDLY HAD NO FEELING IN THE LEFT FOOT AND WAS STARTING TO HAVE FEELING IN THE RIGHT FOOT, WHICH WAS ATTRIBUTED BY THE PHYSICIAN TO LOCAL ANESTHESIA AND EXPECTED TO RESOLVE IN A FEW HOURS. PROLONGATION OF EXISTING HOSPITALIZATION OCCURRED, AND CONSIDERATION WAS GIVEN TO PERFORMING A COMPUTED TOMOGRAPHY SCAN.

  Patient problems: Extravasation

  MAUDE report 23365078 ↗
• 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 22540162 ↗
• MalfunctionSep 30, 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 VERTEBRAL COMPRESSION FRACTURE OF L2 AND L4. IT WAS REPORTED THAT, AFTER THE PROCEDURE THAT CEMENT HAD EXTRAVASATED INTO THE VENA CAVA. THE LEVELS IMPLANTED WERE L2-L4. PROCEDURE/TECHNIQUE PERFORMED WAS KYPHOPLASTY, NO PATIENT SYMPTOMS WERE REPORTED AS A RESULT OF CEMENT EXTRAVASATION. NO PLAN FOR REVISION SURGERY AT THIS TIME. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332961 ↗
• MalfunctionSep 21, 2022Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS THAT WERE USED IN SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE PATIENT HAD SKIN IRRITATION AND SKIN WAS BUBBLING, SORT OF LIFE A BLISTER DUE TO MONOMER SPLASH.

  Patient problems: Inflammation

  MAUDE report 15460935 ↗
• MalfunctionAug 23, 2022Improper Chemical Reaction; Device Handling Problem; Improper Chemical Reaction; Device Handling Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY DUE TO VERTEBRAL COMPRESSION FRACTURE. IT WAS REPORTED THAT SURGEON STATED THEY COULD NOT GET THE BALLOON TO INFLATE, THERE WAS BLOOD IN THE INFLATION SYRINGE AND IT WAS REPLACED WITH NEW BALLOON. REGARDING THE CEMENT, IT WAS SOAKED IN HOT SALINE BATH WHICH IS NOT PART OF DEVICE LABELING, CEMENT HARDENED QUICKLY IN THE PATIENT LEADING TO AN INADEQUATE FILL AND SIGNIFICANT DELAY IN PROCEDURE TIME. 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 15274410 ↗
• InjuryAug 17, 2022Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH BONE CEMENT USED IN KYPHOPLASTY PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SUCCESSFUL KYPHOPLASTY AND PRESENTED WITH SHORTNESS OF BREATH APPROXIMATELY 3-4 WEEKS P OST-PROCEDURE. IMAGING SHOWED PULMONARY EMBOLISM. PATIENT BEING SYMPTOMATIC INDICATED EXTRAVASATION. THERE WAS CEMENT LEAK WITHIN THE VERTEBRAL BODY TO A VEIN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Dyspnea; Extravasation; Pulmonary Embolism

  MAUDE report 15238430 ↗
• MalfunctionApr 14, 2022Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T12 KYPHOPLASTY. IT WAS REPORTED THAT THE PHYSICIAN WENT UNILATERAL WITH THE STRAIGHT AND UNFORTUNATELY SOME CEMENT LEAKED OUT POSTERIOR. 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 14112871 ↗
• MalfunctionMar 22, 2022Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERWENT KYPHOPLASTY SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO CHEST PAIN AND TROUBLE BREATHING AFTER PERFORMING A T11 AND T12 UNIPEDICULAR KYPHOPLASTY. THE PATIENT HAD PULMONARY EMBOLISM AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT A SMALL AMOUNT OF CEMENT LEAKED OUTSIDE THE VERTEBRAL BODY INTO THE VERTEBRAL DISC SPACE. AFTER THE PROCEDURE, 3 DAYS POST-OP, THE PATIENT COMPLAINED OF SHORTNESS OF BREATH AND NO REVISION SURGERY IS PLANNED OR SCHEDULED.

  Patient problems: Dyspnea; Extravasation; Pain; Pulmonary Embolism

  MAUDE report 13852816 ↗
• MalfunctionSep 2, 2021Leak/Splash; Improper Chemical Reaction; Leak/Splash; Improper Chemical Reaction

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION INVOLVED IN THE REPORTED EVENT. LEVELS IMPLANTED- 2. IT WAS REPORTED THAT INTRA-OPERATIVELY, FIRST CURVED NEEDLE WAS CLOGGED WITH XPEDE CEMENT, REMIXED, AND FILLED WITH HVR WHICH WAS TOO RUNNY. MIX TIME WAS 30 SECONDS FOR XPEDE SINCE ROOM TEMPERATURE WAS >72 DEGREES, HVR WAS MIXED FOR APPROXIMATELY 1 MINUTE BUT WAS NOT DOUGHY UPON INJECTION. HVR WAS IMPLANTED IN T5 WAS TOO RUNNY THROUGH THE CURVED NEEDLE AND EXTRAVASATED WHAT IT SEEMED ANTERIOR; PATIENT HAD NO SYMPTOMS. T6 PHYSICIAN USED THE CDS GUN THROUGH A REGULAR BONE FILLER. THERE WAS A MALFUNCTION OF THE CDS SYSTEM DURING USE. HVR WAS TOO RUNNY, AND IT WAS THOUGHT TO BE RESPONSIBLE FOR THE EXTRAVASATION. CEMENT WAS NOT DOUGHY AND HOMOGENOUS PRIOR TO DELIVERY INTO THE PATIENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ON 2021-AUG-25, RECEIVED ADDITIONAL INFORMATION THAT CEMENT EXTRAVASATION OCCURRED AT T6. NO REVISION SURGERY PLANNED/SCHEDULED TO EXPLANT THE CEMENT THAT EXTRAVASATED. PATIENT WITH PRE-OP DIAGNOSIS- VERTEBR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12415549 ↗
• MalfunctionJul 26, 2021Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE (VCF) L5 INVOLVED IN THE REPORTED EVENT. IT WAS REPORTED THAT DURING PROCEDURE, CEMENT WAS MIXED FOR 60 SECONDS AND BONE FILLERS WERE LOADED. CEMENT WAS USED AT 12 MINUTES POST MIX AND TWO OUT OF 6 BONE FILLERS WERE THICK BUT USABLE, HOWEVER THE OTHER 4 HAD HARDENED IN THE BONE FILLERS. ROOM WAS IN NORMAL TEMPERATURE RANGE AND BONE FILLERS WERE NOT HANDLED AFTER FILLING. LABELING WAS FOLLOWED THROUGHOUT THE PROCEDURE. NO PATIENT ADVERSE EVENTS ASSOCIATED WITH THE CEMENT. CEMENT MIXED FOR 60 SECONDS. NO MALFUNCTION OF THE CDS SYSTEM DURING USE. CEMENT WAS DOUGHY AND HOMOGENOUS PRIOR TO DELIVERY INTO THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NEW PRODUCT. PATIENT IS ALIVE AND NO INJURY. ON 2021-JUL-01, RECEIVED ADDITIONAL INFORMATION THAT PROCEDURE WAS KYPHOPLASTY. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR 15 MINUTES. THIS EVENT OCCURRED ON THE BACK TABLE. 2-BONE FILLER USED IN THE PATIENT. REMAINING 4 BONE FILLERS WERE CEMENT HAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225547 ↗
• MalfunctionJul 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THEY BEGAN CEMENTING T9, NOTICED CEMENT LEAK POSTERIORLY AND INJECTION WAS STOPPED. LEVELS IMPLANTED- T8/T9. IT IS ALSO MENTIONED CEMENT WAS USED ALONG WITH ANOTHER VENDORS FENESTRATED SCREW. THEY MENTIONED THERE COULD BE SOME EXTRAVASATION AND CONTINUED WITH THE CASE, THE REMAINING 3 SCREWS WERE AUGMENTED AND THE REMAINDER OF THE CASE WAS COMPLETED SUCCESSFULLY. THERE WAS NO MALFUNCTION OF THE CDS SYSTEM DURING USE. CEMENT WAS MIXED FOR 60-SECONDS. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT PERFORMED AS RESULT OF THE EVENT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: Extravasation

  MAUDE report 10287556 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY DUE TO VERTEBRAL COMPRESSION FRACTURE AT L2. POST-OP, PATIENT WAS EXPERIENCING AN ACUTE INFLAMMATORY RESPONSE AND EXTREME PAIN AT THE SITE OF A KYPHOPLASTY SURGERY. WHILE THE DOCTOR IS NOT CERTAIN THAT CEMENT IS THE CAUSE OF THIS BUT HE WAS CONCERNED THAT IT MIGHT BE RELATED.

  Patient problems: Inflammation; Pain

  MAUDE report 9680003 ↗
• MalfunctionSep 17, 2019Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT UNDERWENT VERTEBRAL AUGMENTATION SURGERY AT L3 DUE TO VERTEBRAL COMPRESSION FRACTURE SECONDARY TO O STEOPOROSIS. INTRA-OPERATIVELY, THE CEMENT WAS MIXED IN THE NORMAL 45 SECOND FASHION BUT SOLIDIFIED IMMEDIATELY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE NEW PRODUCT. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. CEMENT WAS NOT STORED AT PROPER TEMPERATURE(S) BEFORE AND DURING THE PROCEDURE(BELOW 25°C DURING STORAGE; 23 +/-1°C FOR 24 HOURS PRIOR TO USE). CEMENT WAS TAKEN FROM MY TRUNK STOCK. TEMPERATURE WAS IN LOW 90'S. CEMENT DOUGHY AND HOMOGENOUS PRIOR TO DELIVERY INTO THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9074413 ↗
• InjuryMay 11, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY AT T6 DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, DURING CEMENT INJECTION INTO THE VERTEBRAL BODY, CEMENT WAS NOTICED TO BE LEAKING FROM THE POSTERIOR SIDE INTO SPINAL CANAL. WHEN THE ISSUE WAS NOTICED, THE PHYSICIAN STOPPED THE USE OF CEMENT IMMEDIATELY. POST-OP, THE PATIENT EXPERIENCED NUMBNESS IN FEET AS A RESULT OF THIS EVENT. CEMENT WAS MIXED FOR ABOUT 3 MINUTES AND IT WAS DOUGHY AND HOMOGENEOUS PRIOR TO DELIVERY INTO THE PATIENT.

  Patient problems: Numbness

  MAUDE report 8602220 ↗
• MalfunctionDec 12, 2018Migration; Migration

  PROCEDURE TYPE: KYPHOPLASTY IT WAS REPORTED THAT INTRA-OP, THERE WAS AN OCCURENCE OF CEMENT EXTRAVASATION. THERE IS NO KNOWN IMPACT OR CONSEQUENCE OF THE REPORTED EVENT ON THE PATIENT. THE ADVERSE EVENT WAS DETERMINED TO BE RELATED TO THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8154549 ↗
• MalfunctionDec 11, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY AT L2 DUE TO COMPRESSION FRACTURE OF L2 VERTEBRAL BODY. POST-OP, THE CEMENT LEAKED OUTSIDE OF THE VERTEBRAL BODY. THE PATIENT HAD A SLIGHT ARRYTHMIA THAT HAD RESOLVED. PATIENT STILL HAD SLIGHT RIB PAIN THAT THE SURGEON BELIEVES COULD BE FROM POSITIONING ON TO THE OPERATION TABLE. DOCTOR WAS CONCERNED ABOUT PREVENTING CEMENT FROM BREAKING OFF AND CAUSING A PULMONARY EMBOLISM OR TRAVELLING INTO THE HEART. FROM CT SCAN IT WAS FOUND THAT THE CEMENT HAD LEAKED OUTSIDE OF THE VERTEBRAL BODY AND TRAVELLED ABOUT 4CM INSIDE THE VENA CAVA. PATIENT SYMPTOMS RESOLVED AND THE PATIENT IS HAVING NO OTHER SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8149899 ↗
• MalfunctionOct 30, 2018Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY SURGERY DUE TO VERTEBRAL COMPRESSION FRACTURE (VCF). INTRA-OP, CEMENT HARDENED AND HARDLY CAME OUT OF MIXER. THERE WAS A DELAY IN OVERALL PROCEDURE TIME. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8018004 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041584. One submission often covers many models, so check the product and lot details in each record.

• Z-1624-2011 · Nov 10, 2009 · Terminated
  Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two
• Z-1625-2011 · Nov 10, 2009 · Terminated
  Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kypho