KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack CX01B (UDI 00643169097797)Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00643169097797), received between Oct 22, 2018 and Sep 2, 2026 — classified as 3 deaths, 10 injuries, 54 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, 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 25 most recent of 67 reports, 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 ↗
• MalfunctionJun 12, 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 KYPHOPLASTY SPINAL THERAPY FOR VERTEBRAL FRACTURE. IT WAS REPORTED THAT CEMENT WAS NOT DOUGHY AND HOMOGENOUS PRIOR TO DELIVERY, WAS TOO VISCOUS, AND HARDENED FASTER THAN THE LABEL INDICATED. THE BONE CEMENT WOULD NOT PLUNGE INTO THE BONE FILLER OR CARTRIDGES AND COULD NOT BE EXPELLED FROM THE PLUNGER, RESULTING IN A DELAY IN THE OVERALL PROCEDURE TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE LEVELS INVOLVED WAS T6 AND DELAY IN THE OVERALL PROCEDURE IS LESS THAN 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191813 ↗
• MalfunctionJun 10, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY SPI NAL THERAPY. IT WAS REPORTED THAT THE CEMENT APPEARED TO LEAK ANTERIORLY. SURGEON ABORTED THE PROCEDURE AND REQUESTED THE PATIENT BE MONITORED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE PATIENT WAS DIAGNOSED WITH A VERTEBRAL COMPRESSION FRACTURE. A KYPHOPLASTY WAS PERFORMED AND CEMENT WAS INJECTED AT T12. THE PATIENT WAS MONITORED AND RELEASED WITHOUT COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE CEMENT LEAKED OUT OF THE BODY OF THE VERTEBRAE. THE PATIENT EXPERIENCED NO COMPLICATIONS BUT ABORTED THE PROCEDURE. THE CEMENT WAS NOT RETURNED. IT WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174341 ↗
• MalfunctionMay 12, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT THE SCRUB TECH MIXED CEMENT FOR 40 SECONDS AND THE CONSISTENCY LOOKED CLUMPY AND LUMPY. MIXING WAS ABORTED AND ANOTHER KIT WAS OPENED WITH NO ISSUE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002016 ↗
• MalfunctionApr 22, 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 SPINAL THERAPY FOR VERTEBRAL FRACTURES FROM CANCER TREATMENTS. IT WAS REPORTED THAT DURING THE PROCEDURE, THE CEMENT WAS MIXED FOR 35 SECONDS, WITH HANDS POSITIONED ON THE BASE RATHER THAN THE SHAFT. THE PROCESS WAS BRIEFLY INTERRUPTED TO ATTEND TO A HAND SURGEON WITH A CURETTE. UPON RETURNING TO PLUNGE THE CEMENT INTO THE CANISTERS, IT WAS DISCOVERED THAT THE CEMENT HAD ALREADY SET AND HARDENED, MAKING IT IMPOSSIBLE TO PLUNGE INTO THE CANISTERS. IT WAS CONFIRMED THAT THE ROOM TEMPERATURE WAS 65 DEGREES. A SECOND BATCH WAS MIXED USING THE EXACT SAME TECHNIQUE, AND THIS TIME, THE CEMENT SET AS EXPECTED. 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 21880067 ↗
• MalfunctionFeb 7, 2025Coagulation in Device or Device Ingredient; Nonstandard Device; Coagulation in Device or Device Ingredient; Nonstandard Device

  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 THE CEMENT DELIVERY SYSTEM (CDS) MALFUNCTIONED, AS THE CEMENT DID NOT ADVANCE INTO THE BODY DESPITE REPEATED ATTEMPTS. IT WAS KEPT PUMPING THE HANDLE OF THE GUN BUT THERE WAS NO ADVANCEMENT OF THE CEMENT AND NOTICED THAT SALINE WAS DRIPPING AND THEN THE BAG EXPLODED INSIDE THE GUN AND WATER WENT EVERYWHERE. THIS NECESSITATED THE REPLACEMENT OF THE GUN. ADDITIONALLY, THE CEMENT WAS DESCRIBED AS TOO VISCOUS, NOT DOUGHY OR HOMOGENOUS PRIOR TO DELIVERY, AND SUBSEQUENTLY HARDENED TOO QUICKLY, CAUSING FURTHER PROCEDURAL DELAYS. A NEW BATCH OF CEMENT WAS MIXED, BUT IT ALSO HARDENED IMMEDIATELY, REQUIRING ANOTHER BATCH TO BE PREPARED. PROCEDURE/TECHNIQUE PERFORMED WAS KYPHOPLASTY. THE PROCEDURE WAS ULTIMATELY COMPLETED SUCCESSFULLY USING A NEW PRODUCT. THE LEVEL PLANNED TO TREAT WAS T12. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21330825 ↗
• MalfunctionJan 31, 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 KYPHOPLASTY SPI NAL THERAPY. LEVELS IMPLANTED AT L-3. IT WAS REPORTED THAT CEMENT SETUP ABNORMALLY FAST. HARDLY ABLE TO GET CEMENT INTO CARTRIDGES. 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 21280856 ↗
• MalfunctionDec 12, 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 VCF AT T12. IT WAS REPORTED THAT THE CEMENT WAS HARDENED QUICKLY. AFTER CEMENT MIXED, IT WOULD NOT PUSH INTO THE CARTRIDGES. APPEARED TO HAVE DRIED CEMENT IN LUER LOCK CHANNEL WHERE T-CONNECTOR ATTACHES. UNABLE TO CLEAR THE DRIED CEMENT FROM THE CHANNEL. NEW CEMENT AND MIXER OF SAME LOT WAS OPENED AND USED WITHOUT ISSUE. 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 20912284 ↗
• MalfunctionSep 17, 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 FOR OSTEOPOROSIS WITH FRACTURE (T4). IT WAS REPORTED THAT THE ISSUE OCCURRED 2 TIMES. BOTH TIMES WERE WITH THE SAME LOT NUMBERS OF EACH PRODUCT. THE SCRUB MIXED THE XPEDE CEMENT FOR 30 SECONDS BOTH TIMES PER LABELING. WHEN THEY ATTEMPTED TO PUSH THE CEMENT FROM THE MIXER TO THE CDS CARTRIDGES, THE CEMENT WOULD NOT PUSH THROUGH, DESPITE GREAT FORCE. AFTER 2 FAILED ATTEMPTS, WE OPENED UP A THIRD CX01B, SAME LOT NUMBER AND MIXED FOR ONLY 20 SECONDS PER THE MD¿S RECOMMENDATION. THIS ALLOWED THE CEMENT TO BE PUSHED INTO THE CARTRIDGES, BUT STILL REQUIRED NOTICEABLE FORCE TO DO SO. IT APPEARED AS THOSE THE CEMENT WAS TOO HARD IN ORDER TO BE PUSHED THROUGH. HOWEVER, THROUGH TROUBLESHOOTING, THE SCRUB WAS ABLE TO PUSH A NEEDLE (THE NEEDLE THAT COMES WITH THE CX01B KIT) THROUGH THE T-BAR ATTACHMENT WITH THE CARTRIDGES DISCONNECTED AND THEY WERE ALSO ABLE TO PUSH THE NEEDLE THROUGH THE VALUE OF THE MIXING TOWER. THE CEMENT WAS THICKER THAN TYPICAL, BUT STILL SOMEWHAT VISCOUS. THE ROOM TEMPERATURE WAS ABOUT 24 DEGREES C FOR THE ENTIRE PROCEDURE AND THE CEMENT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238822 ↗
• MalfunctionAug 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 ANTERIOR SCOLIO SIS CORRECTION (ASC) SPINAL THERAPY FOR VERTEBRAL COMPRESSION FRACTURE (VCF) AT T12. IT WAS REPORTED THAT THERE IS DIFFICULTY GETTING MIXING AGITATOR TO FIT INSIDE MIXER AND HAD DIFFICULTY MIXING. 15-20 SECONDS PASSED BEFORE STARTED MIXING DUE TO DIFFICULTIES. THERE WAS DIFFICULTY PUSHING CEMENT INTO BONE FILLERS FAST ENOUGH. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20074278 ↗
• MalfunctionAug 12, 2024Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR KYPHOPLASTY. IT WAS REPORTED THAT CEMENT HAS BEEN CLUMPY, DIFFICULT TO MIX, DIFFICULT TO PUSH INTO CDS CARTRIDGES, AND NOT APPEARING OR MIXING AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19959280 ↗