KYPHON® Xpede™ Bone Cement CX01ARecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00643169097803), received between Jan 15, 2019 and Sep 30, 2026 — classified as 2 deaths, 6 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Coagulation in Device or Device Ingredient

  Information was received from a health care provider via a manufacturing representative regarding an event involving a bone cement product used during a vertebroplasty procedure for an L1-L2 vertebral compression fracture. The bone cement was prepared in accordance with the manufacturer¿s instructions and SOP. During transfer into the delivery syringes, the material demonstrated an abnormally rapid increase in viscosity and became excessively thick, preventing injection through the standard delivery cannula. The primary package was discarded, and a new package of bone cement was opened, mixed, and successfully used to complete the procedure. The procedure was completed without further delay or clinical complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945683 ↗
• MalfunctionSep 18, 2026Coagulation in Device or Device Ingredient

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a patient having kyphoplasty ver tebral augmentation with balloon and bone cement. It was reported that the mixed bone cement could not be expelled from the mixing kit. 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 50815382 ↗
• MalfunctionAug 6, 2026Coagulation in Device or Device Ingredient; Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50153372 ↗
• MalfunctionAug 6, 2026Coagulation in Device or Device Ingredient; Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50153337 ↗
• MalfunctionFeb 3, 2026Coagulation in Device or Device Ingredient; Product Quality Problem

  INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROVIDER (HCP) VIA MANUFACTURE REPRESENTATIVE REGARDING A PRODUCT USED IN OSTEOCOOL SPINAL THERAPY FOR THORACIC PAIN, METASTASIS TO VERTEBRAL BODY AT LEVEL T11. IT WAS REPORTED THAT DURING AN OSTEOCOOL CASE INVOLVING MIXER AND CEMENT, SURGEON EXPERIENCED SIGNIFICANT DIFFICULTY MIXING THE BONE CEMENT DESPITE FOLLOWING PROPER TECHNIQUE AND LABELING INSTRUCTIONS. THE CEMENT DID NOT ACHIEVE THE NORMAL SMOOTH CONSISTENCY, AND LARGE CHUNKS OF POWDERED CEMENT WERE OBSERVED STUCK TO THE MIXER. AFTER THE INITIAL MIXING, ONLY 1-2 CC OF CEMENT COULD BE EXTRUDED INTO CARTRIDGES BEFORE IT BECAME VERY DIFFICULT TO PUSH OUT ANYMORE. BOTH WERE UNABLE TO PUSH MORE THAN 1 CC OF CEMENT INTO THE EGG, AND TWO SETS OF PREVIOUSLY MIXED CEMENT WERE DISCARDED BY THE FACILITY. THE ISSUE WAS RESOLVED BY ASSEMBLING A NEW CEMENT KIT AND USING THE INCLUDED SYRINGE AND NEEDLE TO DRAW UP THE LIQUID COMPONENT, WHICH RESULTED IN EASIER MIXING AND THE CORRECT CONSISTENCY. THE CEMENT WAS THEN SUCCESSFULLY DELIVERED VIA CDS GUN AND BONE FILLER WITHOUT FURTHER ISSUE. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24243484 ↗
• MalfunctionFeb 3, 2026Coagulation in Device or Device Ingredient; Product Quality Problem

  INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROVIDER (HCP) VIA MANUFACTURE REPRESENTATIVE REGARDING A PRODUCT USED IN OSTEOCOOL SPINAL THERAPY FOR THORACIC PAIN, METASTASIS TO VERTEBRAL BODY AT LEVEL T11. IT WAS REPORTED THAT DURING AN OSTEOCOOL CASE INVOLVING MIXER AND CEMENT, SURGEON EXPERIENCED SIGNIFICANT DIFFICULTY MIXING THE BONE CEMENT DESPITE FOLLOWING PROPER TECHNIQUE AND LABELING INSTRUCTIONS. THE CEMENT DID NOT ACHIEVE THE NORMAL SMOOTH CONSISTENCY, AND LARGE CHUNKS OF POWDERED CEMENT WERE OBSERVED STUCK TO THE MIXER. AFTER THE INITIAL MIXING, ONLY 1-2 CC OF CEMENT COULD BE EXTRUDED INTO CARTRIDGES BEFORE IT BECAME VERY DIFFICULT TO PUSH OUT ANY MORE. BOTH WERE UNABLE TO PUSH MORE THAN 1 CC OF CEMENT INTO THE EGG, AND TWO SETS OF PREVIOUSLY MIXED CEMENT WERE DISCARDED BY THE FACILITY. THE ISSUE WAS RESOLVED BY ASSEMBLING A NEW CEMENT KIT AND USING THE INCLUDED SYRINGE AND NEEDLE TO DRAW UP THE LIQUID COMPONENT, WHICH RESULTED IN EASIER MIXING AND THE CORRECT CONSISTENCY. THE CEMENT WAS THEN SUCCESSFULLY DELIVERED VIA CDS GUN AND BONE FILLER WITHOUT FURTHER ISSUE. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24243469 ↗
• MalfunctionDec 8, 2025Coagulation in Device or Device Ingredient; Device Damaged Prior to Use; Coagulation in Device or Device Ingredient; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY (BKP) SPINAL THERAPY FOR VERTEBRAL COMPRESSION FRACTURE (VCF). LEVELS IMPLANTED WAS T12. IT WAS REPORTED THAT DURING A PROCEDURE, THE CEMENT FAILED TO THICKEN ADEQUATELY AFTER MIXING, AND AS A RESULT, THE CEMENT WAS NEVER IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE CEMENT WAS RUNNY AND DIDN¿T SET UP FAST ENOUGH TO BE USED IN THE PATIENT. THE PATIENT DID NOT RECEIVE CEMENT AS IT WAS NOT USED ON THE PATIENT. THERE WAS A 10 MINUTE DELAY DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23740402 ↗
• MalfunctionOct 15, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH VERTEBRAL COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BONE CEMENT WAS MIXED FOR 30 SECONDS ACCORDING TO LABEL GUIDELINES. ALL CEMENT POWDER AND ALL THE MONOMER WERE USED IN ENTIRETY. AFTER ONLY 30 SECONDS OF MIXING, THE CEMENT BECAME IMPOSSIBLE TO PLUNGE INTO CDS CARTRIDGES AS IT HARDENED ABNORMALLY QUICKLY. AS A RESULT, THIS BATCH OF CEMENT WAS UNUSABLE AND WAS NOT INJECTED INTO THE PATIENT. A SECOND CX01B WAS OPENED AND A SECOND BATCH OF CEMENT WAS THEN PREPARED USING THE EXACT SAME METHOD, WHICH INJECTED OPTIMALLY. THE PATIENT WAS NOT AFFECTED BY THIS. 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 23288451 ↗
• MalfunctionJul 29, 2025Leak/Splash; Manufacturing, Packaging or Shipping Problem; Leak/Splash; Manufacturing, Packaging or Shipping Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY, DISTRIBUTOR) REGARDING A PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE OUTER PACKAGING OF THE CEMENT WAS WET UPON RECEIPT, AND IT WAS SUSPECTED THAT A LIQUID CONTAINER MAY HAVE LEAKED OR BROKEN. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22640643 ↗
• MalfunctionJun 6, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT H AVING SPINAL THERAPY FOR T12 COMPRESSION FRACTURE. IT WAS REPORTED THAT THE MIXTURE OF POWDER AND LIQUID WAS TOO VISCOUS DUE TO AN INSUFFICIENT AMOUNT OF LIQUID, MAKING CEMENT UNSUITABLE FOR USE. THE CEMENT WAS NOT USED IN THE PATIENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22160175 ↗
• MalfunctionDec 10, 2024Coagulation 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 T-12 BALLOON KY PHOPLASTY (BKP). IT WAS REPORTED THAT THE CEMENT BECAME VERY HARD IN THE TROCAR WITHIN APPROXIMATELY 6 MINUTES. 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 20889750 ↗
• MalfunctionSep 27, 2024Coagulation 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 SPINAL THERAPY. IT WAS REPORTED THAT THE CEMENT COAGULATED FASTER. WHILE MIXING CEMENT IN NORMAL SITUATION CEMENT CAME OUT VERY THICK. IT BROKE THE HEAD OFF OF THE MIXER WHILE PULLING IT OUT OF TUBE. UNABLE TO GET THICK CEMENT TO RELEASE FROM THE MIXER. TRIED TO PLUNGE CEMENT INTO CANISTERS FOR DELIVERY AND COULD NOT GET IT TO FILL CANISTERS. EVENTUALLY OPENED A SECOND KIT AS WELL AS CEMENT KIT AND HAD NO ISSUES. 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 EVENT OCCURRED DURING SET-UP AT BACK TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320115 ↗
• MalfunctionSep 16, 2024Coagulation 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 KYPHOPLASTY FOR VERTEBRAL COMPRESSION FRACTURE. IT WAS REPORTED THAT AFTER MIXING CEMENT PER IFU FOR 30 SECONDS THE CEMENT WAS VERY THICK. UNABLE TO FILL THE REQUIRED NUMBER OF BONE FILLERS FOR THE PROCEDURE. 2 OF 8 BFDS WERE FILLED. THE CEMENT WAS TOO VISCOUS. THE PROCEDURE COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. THERE WAS A DELAY OF 10 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 20222548 ↗
• MalfunctionJun 21, 2024Leak/Splash; Product Quality Problem; Leak/Splash; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT WHEN OPENED THE XPEDE CEMENT IT WAS FOUND THAT THE LIQUID PART HAD LEAKED WITHIN THE PACKET . THERE WERE NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582219 ↗
• MalfunctionApr 30, 2024Coagulation 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 L1 LUMBAR KYPHO PLASTY FOR AN INDICATION OF VERTEBRAL COMPRESSION FRACTURE. IT WAS REPORTED THAT WHEN THE CEMENT WAS MIXED AND BEGAN FILLING THE BFD, THE CEMENT HARDENED TOO QUICKLY (APPROXIMATELY IN 2 MINUTES). THE REQUIRED NUMBER OF BFDS WERE NOT ABLE TO BE FILLED. 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 19210618 ↗
• MalfunctionApr 15, 2024Coagulation 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. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE - T7 COMPRESSION FRACTURE. IT WAS REPORTED THAT THE CEMENT BECAME TOO HARD TO FILL THE BONE FILLERS AT THE 3 MINUTE MARK. 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 CEMENT WAS INJECTED INTO THE PATIENT MANUALLY WITH 10 GAUGE BONE FILLERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19103634 ↗
• InjuryNov 9, 2023Coagulation in Device or Device Ingredient; Leak/Splash; Coagulation in Device or Device Ingredient; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T9 KYPHOPLASTY FOR VERTEBRAL COMPRESSION FRACTURE. IT WAS REPORTED THAT CEMENT HARDENED BY MINUTE 12 WHEN THEY WERE FINISHED INJECTING CEMENT INTO PATIENT AND TRYING TO GET CDS BFD OUT OF CANNULA. ONCE THEY GOT CDS BFD OUT, AROUND 12.5 MINUTES, THEY TRIED TO PUT THE INNER STYLET BACK INTO CANNULA AND ONLY GOT IT HALFWAY DOWN. THEY DID NOT WANT TO RISK THE CANNULA GETTING STUCK IN THE PATIENT WITH CEMENT HARDENING, SO REMOVED THE SYSTEM. CEMENT FOLLOWED CANNULA OUT INTO PEDICLE TO THE SKIN FULLY HARDENED. CLIPPED AS MUCH AS POSSIBLE, BUT A PIECE REMAINED IN TISSUE AGAINST RIB. THE FACILITY HAS HUMIDITY ISSUES DUE TO FACILITY NOT HAVING PROPER INSULATION WHEN BUILT FOR MEDICAL SPACE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Extravasation; Foreign Body In Patient

  MAUDE report 18099041 ↗
• MalfunctionNov 9, 2021Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM A HCP VIA CLINICAL STUDY REGARDING A PATIENT WITH CLINICAL ID:(B)(6). CLINICAL STUDY NUMBER: (B)(4). PATIENT MEDICAL HISTORY: HYPERTENSION; OSTEOPOROSIS; OSTEOPENIA; GASTROINTESTINAL; CHRONIC GASTRITIS; IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT WENT TO (B)(6) HOSPITAL FOR 6-MONTH X-RAY EXAMINATION, WHICH REVEALED BONE CEMENT EXUDATION. OUTCOME: RECOVERING/RESOLVING  INVESTIGATOR ASSESSMENT: IS THIS AE RELATED TO A STUDY PROCEDURE: NOT RELATED; IS THE AE RELATED TO THE BONE CEMENT: PROBABLE; IS THE AE RELATED TO ANY OTHER COMPONENTS USED DURING THE PROCEDURE: POSSIBLE; IS THE AE RELATED TO AN UNDERLYING CONDITION OR DISEASE: POSSIBLE; WHAT WAS THE RATIONALE FOR THE RELATIONSHIP TO SYSTEM OR PROCEDURE: NOT RELATED. SPONSOR ASSESSMENT: PROBABLE RELATED TO BONE CEMENT; POSSIBLE RELATED TO UNDERLYING CONDITION; NOT RELATED TO PROCEDURE, OTHER COMPONENTS. OUTCOME: RECOVERING/RESOLVING  THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. UPDATED INFORMATION RECEIVED ON 21-OCT-2021: AE DESCRIPTION: ON (B)(6) 2021, THE PATIENT WENT TO (B)(6) HOSPITAL FOR 6-MONTH X-RAY EXAMINATION, WHICH REVEALED BONE CEMENT EXUDATION. NO STATEMENTS IN THE A

  Patient problems: Extravasation

  MAUDE report 12777528 ↗
• MalfunctionMay 4, 2021Clumping in Device or Device Ingredient; Coagulation in Device or Device Ingredient; Clumping in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT TYPE FOR UNKNOWN INDICATION. IT WAS REPORTED THAT WHILE PERFORMING A KYPHOPLASTY PROCEDURE AND PREPARING FOR CEMENT FOR INJECTION, IT WAS REPORTED THAT SHORTLY AFTER POURING IN THE MONOMER AND TRYING TO MIX ,THE CEMENT BECAME VERY "CLUMPY." STAFF CONTINUED TO TRY TO MIX THE CEMENT BUT IT BECAME INCREASINGLY DIFFICULT AS THEY CEMENT CONTINUED TO HARDEN IN A VERY SHORT PERIOD OF TIME (LESS THAN 30 SECONDS). AS A RESULT CEMENT AND MIXER WAS DISCARDED AND IT WAS REPLACED WITH A DIFFERENT CX01B CEMENT AND MIXER. THE CASE WAS THEN SUCCESSFULLY COMPLETE WITHOUT ISSUE. DELAY WAS ONLY A COUPLE OF MINUTES TO OPEN AND MIX REPLACEMENT CEMENT (LESS THAN 5 MINUTES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11768509 ↗
• InjuryApr 29, 2021Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT TYPE FOR VERTEBRAL COMPRESSION FRACTURE AT T8. IT WAS REPORTED THAT CEMENT LEAKED OUT OF ANTERIOR TO THE VERTEBRAL BODY AND TRAVELED INTO LUNG AREA CAUSING A PULMONARY EMBOLISM. PATIENT DEVELOPED CHEST PAIN AND WAS PLACED ON BLOOD THINNERS. PATIENT WAS HOSPITALIZED FOR AN EXTRA DAY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ORIGINAL PRODUCT. EVENT IS NOT RELATED TO USER ERROR. THERE IS NO MALFUNCTION WITH THE KIT.

  Patient problems: Chest Pain; Extravasation; Pulmonary Embolism

  MAUDE report 11743433 ↗
• MalfunctionMar 26, 2021Product Quality Problem; Chemical Problem; Product Quality Problem; Chemical Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A KYPHOPLASTY PROCEDURE IN A PATIENT DIAGNOSED WITH METASTIC BONE TUMOR. IT WAS REPORTED THAT THE CEMENT WAS SETTING TOO FAST. THE CEMENT WAS SO THICK AT 30 SECONDS WE COULD BARELY FILL 6 BONE FILERS. THE CEMENT WAS MIXED FOR 30 SECS AND IT WAS STORED AT PROPER TEMPERATURE. THE CEMENT WAS USED ON THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WILL BE NO PRODUCT RETURN AND NO PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573569 ↗
• MalfunctionMar 26, 2021Product Quality Problem; Chemical Problem; Product Quality Problem; Chemical Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A KYPHOPLASTY PROCEDURE IN A PATIENT DIAGNOSED WITH METASTIC BONE TUMOR. IT WAS REPORTED THAT THE CEMENT WAS SETTING TOO FAST. THE CEMENT WAS SO THICK AT 30 SECONDS WE COULD BARELY FILL 6 BONE FILERS. THE CEMENT WAS MIXED FOR 30 SECS AND IT WAS STORED AT PROPER TEMPERATURE. THE CEMENT WAS USED ON THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WILL BE NO PRODUCT RETURN AND NO PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573566 ↗
• MalfunctionMar 26, 2021Improper Chemical Reaction; Improper Chemical Reaction

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF METASTATIC BONE LESIONS INVOLVED IN KYPHOPLASTY PROCEDURE. IT WAS REPORTED THAT DURING PROCEDURE, THE CEMENT WAS GETTING MUCH THICKER THAN USUAL AND COULD BARELY PUSH IT OUT OF THE MIXER. CEMENT WAS STORED AT PROPER TEMPERATURE(S) BEFORE AND DURING THE PROCEDURE. CEMENT WAS MIXED FOR 25 SECONDS. CEMENT WAS DOUGHY AND HOMOGENOUS PRIOR TO DELIVERY INTO THE PATIENT. NO EXTRAVASATION REPORTED. THERE WERE NO PATIENT ADVERSE EVENTS ASSOCIATED WITH THE CEMENT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573460 ↗
• InjuryJul 30, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AS PATIENT HAVING KYPHOPLASTY DUE OSTEOPOROTIC FRACTURE OF L4. IT WAS REPORTED THAT CEMENT EXTRAVASATION OCCURRED DURING FILLING OF THE L4 VERTEBRAL BODY ON THE LEFT SIDE AND EXTENDED INTO THE PSOAS MUSCLES AT THE MID BODY POSITION. CEMENT WAS AT THE 7 MINUTE POST MIX TIME POINT. POST PROCEDURE PATIENT COMPLAINED OF LEFT SIDED GROIN AND THIGH PAIN AND WAS ADMITTED FOR PAIN CONTROL. IT WAS REPORTED THAT CEMENT WAS MIXED FOR 25 SECONDS. THE PRODUCT WAS IMPLANTED ON (B)(6) 2020 AND REMAINS IMPLANTED. IT WAS REPORTED THAT PATIENT PAIN HAS BEEN RESOLVED AND THERE ARE NO FURTHER SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Extravasation; Pain

  MAUDE report 10343244 ↗
• InjuryMar 29, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT KYPHOPLASTY PROCEDURE AT L5-S1. THE PROCEDURE CONSISTED OF INJECTING BONE CEMENT INTO THE L5 VERTEBRAE ON THE LEFT SIDE. REPORTEDLY, APPROXIMATELY 17 CM OF EXCESS BONE CEMENT EXTRUDED INTO THE PATIENT'S INFERIOR VENA CAVA JUST AFTER THE INJECTION. A SUBSEQUENT CT SCAN CONFIRMED THAT THE PATIENT HAD A LINEAR DENSITY MEASURING APPROXIMATELY 17 CM WITHIN HIS INFERIOR VENA CAVA BEGINNING AT THE LEVEL OF THE T12 VERTEBRAL BODY AND EXTENDING INFERIORLY TO THE LEFT COMMON ILIAC VEIN. UPON RECEIVED INFORMATION AND BELIEF, THE CEMENT RETAINED WITHIN PATIENT'S VENA CAVA WAS INOPERABLE. ALLEGEDLY, THE RETAINED CEMENT COULD FRACTURE AT ANY TIME, RESULTING IN PERFORATION OF INTERNAL STRUCTURES AND ANOTHER VITAL ORGAN(S), POTENTIALLY CAUSING SIGNIFICANT INJURY OR DEATH.

  Patient problems: Extravasation

  MAUDE report 9895034 ↗