KYPHON® HV-R® Bone Cement C01A (UDI 00643169097865)Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00643169097865), received between Apr 28, 2017 and Mar 3, 2026 — classified as 20 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR VERTEBRAL COMPRESSION FRACTURE OF LUMBAR LEVEL 3 AND LUMBAR 4. IT WAS REPORTED THAT THE CEMENT HARDENED PREMATURELY IN THE VERTEBRAL BODY AT L3, PREVENTING REMOVAL OF THE CURETTE AND WORKING CANNULA. THE CURETTE AND WORKING CANNULA WERE PROTRUDING FROM THE STAB INCISION AT L3. BOLT CUTTERS AND A HIGH SPEED DRILL WERE REQUIRED TO REMOVE THE PROTRUDING METAL COMPONENTS. PART OF THE CURETTE AND WORKING CANNULA REMAINED WITHIN THE PATIENT'S BONE. A SMALL INCISION WAS MADE AT THE LEVEL OF THE LEFT L3 PEDICLE TO FACILITATE REMOVAL OF THE EXPOSED MATERIAL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTEDAS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492901 ↗
• MalfunctionFeb 11, 2026Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING VERTEBROPLASTY PROCEDURE FOR AN OSTEOPOROTIC CONDITION ON THE SACRUM. IT WAS REPORTED THAT THE FIRST BOX OF CEMENT WAS MIXED FOR 1 MINUTE AND INJECTED AT 5.5-6 MINUTES, BUT THE CEMENT HAD ALREADY HARDENED, RESULTING IN NO CEMENT BEING INJECTED. THE SECOND BOX WAS MIXED FOR 45 SECONDS AND INJECTED AT THE 3.5-MINUTE MARK; SMALL AMOUNTS OF CEMENT WERE ABLE TO BE INJECTED BEFORE THE CEMENT HARDENED. COMPUTED TOMOGRAPHY WAS USED TO CHECK CEMENT PLACEMENT AND THE AMOUNT INJECTED, REVEALING SMALL AMOUNTS OF CEMENT AT THE POSTERIOR BORDER OF THE SACRUM SURROUNDING THE WORKING PORT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. NO PATIENT SYMPTOMS/COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE THAT WAS INVOLVED WAS BILATERAL SACROPLASTY. THE THIRD BOX OF CEMENT IS THE SAME BATCH AS THE PREVIOUS ONE, THIS IS BATCH WHERE MOST CEMENT ARE INJECTED INTO THE PATIENT BODY. THE MIXING PROCESS AND INSERTION PROCESS IS MUCH EARLIER THAN THE PREVIOUS ONES. THE MIXING TIME WAS 30 SECONDS AND WAS INJ

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311230 ↗
• MalfunctionFeb 11, 2026Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING VERTEBROPLASTY PROCEDURE FOR AN OSTEOPOROTIC CONDITION ON THE SACRUM. IT WAS REPORTED THAT THE FIRST BOX OF CEMENT WAS MIXED FOR 1 MINUTE AND INJECTED AT 5.5-6 MINUTES, BUT THE CEMENT HAD ALREADY HARDENED, RESULTING IN NO CEMENT BEING INJECTED. THE SECOND BOX WAS MIXED FOR 45 SECONDS AND INJECTED AT THE 3.5-MINUTE MARK; SMALL AMOUNTS OF CEMENT WERE ABLE TO BE INJECTED BEFORE THE CEMENT HARDENED. COMPUTED TOMOGRAPHY WAS USED TO CHECK CEMENT PLACEMENT AND THE AMOUNT INJECTED, REVEALING SMALL AMOUNTS OF CEMENT AT THE POSTERIOR BORDER OF THE SACRUM SURROUNDING THE WORKING PORT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. NO PATIENT SYMPTOMS/COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE THAT WAS INVOLVED WAS BILATERAL SACROPLASTY. THE THIRD BOX OF CEMENT IS THE SAME BATCH AS THE PREVIOUS ONE, THIS IS BATCH WHERE MOST CEMENT ARE INJECTED INTO THE PATIENT BODY. THE MIXING PROCESS AND INSERTION PROCESS IS MUCH EARLIER THAN THE PREVIOUS ONES. THE MIXING TIME WAS 30 SECONDS AND WAS INJ

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311229 ↗
• MalfunctionFeb 11, 2026Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING VERTEBROPLASTY PROCEDURE FOR AN OSTEOPOROTIC CONDITION ON THE SACRUM. IT WAS REPORTED THAT THE FIRST BOX OF CEMENT WAS MIXED FOR 1 MINUTE AND INJECTED AT 5.5-6 MINUTES, BUT THE CEMENT HAD ALREADY HARDENED, RESULTING IN NO CEMENT BEING INJECTED. THE SECOND BOX WAS MIXED FOR 45 SECONDS AND INJECTED AT THE 3.5-MINUTE MARK; SMALL AMOUNTS OF CEMENT WERE ABLE TO BE INJECTED BEFORE THE CEMENT HARDENED. COMPUTED TOMOGRAPHY WAS USED TO CHECK CEMENT PLACEMENT AND THE AMOUNT INJECTED, REVEALING SMALL AMOUNTS OF CEMENT AT THE POSTERIOR BORDER OF THE SACRUM SURROUNDING THE WORKING PORT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. NO PATIENT SYMPTOMS/COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE THAT WAS INVOLVED WAS BILATERAL SACROPLASTY. THE THIRD BOX OF CEMENT IS THE SAME BATCH AS THE PREVIOUS ONE, THIS IS BATCH WHERE MOST CEMENT ARE INJECTED INTO THE PATIENT BODY. THE MIXING PROCESS AND INSERTION PROCESS IS MUCH EARLIER THAN THE PREVIOUS ONES. THE MIXING TIME WAS 30 SECONDS AND WAS INJ

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311211 ↗
• MalfunctionJun 9, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CEMENT INJECTION AT TH12 FOR PRIMARY OSTEOPOROSIS- COMPRESSION FRACTURE. IT WAS REPORTED THAT THERE WAS CEMENT OUTFLOW FROM THE SIDE OF THE VERTEBRAL BODY TO THE VEIN. 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 22164846 ↗
• MalfunctionMay 14, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE CEMENT THE MIXTURE TURNED HARD OR DRY, TO SUCH AN EXTENT THAT IT COULD NOT BE STIRRED. 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 22016929 ↗
• MalfunctionNov 28, 2022Coagulation 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 AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT AFTER CEMENT WAS FILLED INTO THE VERTEBRAL BODY, THE BFD IN THE PROCESS OF FILLING WAS PLACED IN THE VERTEBRAL BODY, CAUSING THE CEMENT TO LEAK FROM THE VERTEBRAL BODY INTO THE BFD, LEAK FROM THE VERTEBRAL ARCH ROOT, AND HARDEN. IT IS UNKNOWN WHEN THE CEMENT HARDENED BUT THE ISSUE WAS NOTICED WHEN THE BFD WAS REMOVED AFTER THE HARDENING TIME WAS COMPLETED. 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 15867591 ↗
• InjuryJul 5, 2022Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS VE RTEBROPLASTY FOR PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT THE CEMENT LEAKED INTO THE BLOOD VESSEL. THERE WAS NO EXTRAVASATION. THE PRODUCT WAS USED SUCCESSFULLY. THE CEMENT HAD BEEN STORED AT AN APPROPRIATE TEMPERATURE BEFORE AND DURING THE PROCEDURE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED: LEVEL IMPLANTED: 3RD LUMBAR VERTEBRA THE CEMENT THAT LEAKED INTO THE BLOOD VESSEL. CEMENT FLOWED FROM THE VEINS IN FRONT OF THE VERTEBRAL BODY TO LUNG. THE VENOUS CEMENT HAS BEEN REMOVED WITH A CATHETER. IT COULD BE REMOVED WITHOUT ANY PROBLEMS. THERE WAS AN EXTENSION OF HOSPITALIZATION. THE EXTENSION OF HOSPITALIZATION WAS FOR FOLLOW-UP DUE TO THE CEMENT LEAKAGE.

  Patient problems: Extravasation

  MAUDE report 14912640 ↗
• MalfunctionJul 3, 2022Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT PERCUTAN EOUS VERTEBROPLASTY FOR L4 COMPRESSION FRACTURE SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE CEMENT LEAKED TO THE RIGHT-SIDE REGION OF THE VERTEBRAL BODY. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE HAS NOT BEEN PLANNED ANY ADDITIONAL TREATMENT OR SURGERY FOR THE REMOVAL OF IMPLANT.

  Patient problems: Extravasation

  MAUDE report 14902796 ↗
• InjuryDec 30, 2021Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS POSSIBLE SCREW MIGRATION INVOLVED IN THE REPORTED EVENT. LEVELS IMPLANTED T10; T11. IT WAS REPORTED THAT INTRA-OPERATIVELY, FENESTRATED SCREWS WITH CEMENT. INJECTED CEMENT DOWNSIZES 3 BONE FILLERS AND WATCHED ON XRAY. CEMENT EXTRAVASATED TO SPINAL CANAL. DUE TO EXTRAVASATION IN SPINAL CANAL THE DURAL TEAR WAS REPORTED. ADDITIONAL SURGERY- LAMINECTOMY DONE AND DURAL REPAIR WAS PERFORMED AS A RESULT OF THIS EVENT. THERE WAS DELAY IN OVERALL PROCEDURE TIME. THERE WAS NO MALFUNCTION OF THE CDS SYSTEM DURING USE. CEMENT STORED AT PROPER TEMPERATURE(S) BEFORE AND DURING THE PROCEDURE. CEMENT MIXED FOR 60 SECONDS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ORIGINAL PRODUCTS. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT THERAPY WAS CEMENTING SCREWS. UNKNOWN FORMER SCREWS. ADDED 2 HOURS TO CASE. LEVELS CEMENT EXTRAVASATED T11 AND T12. CEMENT EXTRAVASATED AT IMPLANTED LEVEL AND ONE LEVEL BELOW. ADDITIONAL SURGERY/TREATMENT-LAMINECTOMY AND DURAL REPAIR WAS PERFORMED ON THE SAME DAY.

  Patient problems: Extravasation; Spinal Cord Injury

  MAUDE report 13116447 ↗
• MalfunctionMar 23, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT UNDERWENT KYPHOPLASTY AT L4. INTRA-OP, CEMENT EXTRAVASATION OCCURRED IN THE PARA SPINAL TISSUES. THIS CEMENT EXTRAVASATION WAS FOUND NOT TO BE GREATER THAN 15 MM; AND THE EVENT WAS DETERMINED NOT TO BE CLINICALLY SIGNIFICANT.

  Patient problems: Extravasation

  MAUDE report 9868981 ↗
• MalfunctionFeb 26, 2020Migration; Migration

  THE CEMENT HAD BEEN MIXED PROPERLY AND HAD BEEN FILLED IN A UNIFORM SOFTNESS WITHOUT ANY VISCOSITY PROBLEMS. THERE HAD BEEN NO MIGRATION SINCE THE MIGRATION THAT OCCURRED INITIALLY. CURRENTLY, NO COMPLICATIONS HAVE OCCURRED.

  Patient problems: Extravasation

  MAUDE report 9757576 ↗
• MalfunctionJan 18, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH COMPRESSION FRACTURE AT T12; AND UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, WHEN THE BALLOON WAS INFLATED TO 4CC, THE BALLOON INTERFERED WITH THE ENDPLATE. THERE WAS NO MALFUNCTION WITH THE BALLOON. WHEN THE CEMENT WAS FILLED TO 3.5CC, THE CEMENT LEAKED TO THE LEFT SIDE; HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: Extravasation

  MAUDE report 9604697 ↗
• MalfunctionJan 2, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY DUE TO PRIMARY OSTEOPOROSIS. INTRA-OPERATIVELY, DURING THE OPERATION THE CEMENT CAME INTO THE VEIN ON THE SIDE OF THE VERTEBRAL BODY. AFTER THAT, THE CEMENT SOLIDIFIED. IT WAS CONFIRMED THAT THE CEMENT WHICH CAME INTO THE VEIN ALSO SOLIDIFIED. THE FOLLOWING DAY, IT WAS CHECKED WHEN TAKING CT THAT THE CEMENT WAS NOT ON THE SIDE OF THE VERTEBRAL BODY BUT CAME TO THE LUNGS, AND HAS TURNED TO PULMONARY EMBOLISM. BUT THERE WERE NO SYMPTOMS. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS THE RESULT OF THIS EVENT.

  Patient problems: Pulmonary Embolism

  MAUDE report 9537591 ↗
• MalfunctionDec 6, 2019Migration; Migration

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT UNDERWENT CEMENTOPLASTY. INTRA-OP, CEMENT EXTRAVASATION WAS FOUND AT THE SUPERIOR DISC SPACE AND INFERIOR DISC SPACE. THIS CEMENT EXTRAVASATION WAS FOUND NOT BE EXTRUDED BY MORE THAN 15 MM; AND HENCE, WAS DETERMINED NOT TO BE CLINICALLY SIGNIFICANT.

  Patient problems: Extravasation

  MAUDE report 9424555 ↗
• MalfunctionNov 25, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT L1 DUE TO L1 COMPRESSION FRACTURE AND PSEUDOARTHROSIS. INTRA-OP, DURING CEMENT FILLING, 0.1 CC OF THE CEMENT LEAKED ON THE ANTERIOR SIDE. THE CEMENT WAS FILLED WHILE PULLING THE BONE FILLER DEVICE (BFD) BACKWARDS; AND THE OPERATION WAS FINISHED. IT IS UNKNOWN WHETHER THERE WERE ANY PATIENT COMPLICATIONS OR NOT.

  Patient problems: Extravasation

  MAUDE report 9370945 ↗
• MalfunctionNov 5, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED VIA CLINICAL STUDY THAT INTRA-OP, CEMENT EXTRAVASATION OCCURRED IN THE INFERIOR DISK SPACE OF THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DURING THIS EVENT. THE EVENT WAS RELATED TO SURGICAL PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9277204 ↗
• MalfunctionSep 13, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN SPINAL PROCEDURE DUE TO PRIMARY OSTEOPOROSIS. INTRA-OPERATIVELY, THE CEMENT LEAKED TO THE UP, DOWN AND ANTERIOR SIDE OF THE VERTEBRAL BODY WHILE FILLING THE CEMENT TO THE VERTEBRAL BODY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT.

  Patient problems: Extravasation; No Known Impact Or Consequence To Patient

  MAUDE report 9022088 ↗
• InjuryAug 16, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY AT L3 DUE TO PRIMARY OSTEOPOROSIS. POST-OP, THE PATIENT UNDERWENT POSTERIOR D ECOMPRESSION AND FUSION REVISION SURGERY AT L2-4 DUE TO CEMENT LEAKAGE. THE CEMENT WHICH LEAKED TO THE DURA WAS CUT OFF. PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8901778 ↗
• InjuryJul 12, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNDERWENT KYPHOPLASTY SURGERY DUE TO PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. POST-OP, IN CT SCAN RESULTS IT HAS BEEN IDENTIFIED THAT THE BONE CEMENT EXTRAVASATED INTO THE INFERIOR VENA CAVA (IVC). THERE WERE NO PATIENT PROBLEMS AT THIS TIME. HOWEVER, IN REGARDS TO THE FUTURE, IT IS THAT THE SURGEON OF VASCULAR SURGERY DOES THE OPERATION WITH THE INTENTION OF THE PATIENT. IT IS PLANNED TO INSERT THE CATHETER, AND REMOVE THE CEMENT WITH GRASPING THE WIRE. THE OPERATION DATE IS CURRENTLY UNDECIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8783750 ↗
• MalfunctionJul 1, 2019Migration; Migration

  IT WAS REPORTED PER CLINICAL STUDY THAT ON (B)(6) 2018, THE PATIENT UNDERWENT KYPHOPLASTY AT L1. INTRA-OP, CEMENT EXTRAVASATION OCCURRED AT INTRAVASCULAR REGION. CEMENT VOLUME IMPLANTED WAS 3CC. THE CEMENT DID NOT EXTRUDE MORE THAN 15MM; AND CEMENT EXTRAVASATION WAS NOT DETERMINED TO BE CLINICALLY SIGNIFICANT BY THE INVESTIGATOR. SPONSOR ASSESSMENT DETERMINED THE EVENT TO BE RELATED TO THE PROCEDURE; AND NOT RELATED TO ANY OF THE DEVICES. THE OUTCOME OF THE EVENT WAS NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8747136 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE LEVELS IMPLANTED: T11-L5 IT WAS REPORTED THAT THE PATIENT UNDERWENT A KYPHOPLASTY AT L1, L3. POST-OP, COLLAPSE OCCURRED AT L1 AND PATIENT EXPERIENCED NEUROLOGICAL SYMPTOMS DUE TO OSTEOPHYTE INVAGINATION INTO THE SPINAL CANAL. HENCE, POSTERIOR FUSION WAS PERFORMED AS A RESULT OF THE EVENT.

  Patient problems: Collapse; Neurological Deficit/Dysfunction

  MAUDE report 8244747 ↗
• MalfunctionDec 31, 2018Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH PRIMARY OSTEOPOROSIS AND HAD COMPRESSION FRACTURE AND UNDERWENT BALLOON KYPHOPLASTY (BKP) SURGERY. DURING SURGERY, WHILE INJECTING THE BONE CEMENT INTO THE PATIENT, THE CEMENT BEGAN TO SOLIDIFY. THEREFORE, THE CEMENT WAS INJECTED INTO THE VERTEBRAL BODY QUICKLY. 3CC CEMENT WAS INJECTED IN THE RIGHT SIDE AND 2.5CC CEMENT WAS INJECTED AT THE LEFT SIDE. THE PHYSICIAN WANTED TO INJECT A LITTLE MORE CEMENT BUT COULD NOT DO SO. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE OPERATION WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8205662 ↗
• 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 8154537 ↗
• MalfunctionNov 14, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT TH12 DUE TO PRIMARY OSTEOPOROSIS, COMPRESSION FRACTURE. INTRA-OPERATIVELY, WHEN CEMENT WAS INJECTED AT TH12, IT LEAKED FORWARD. LEAKAGE(APPROXIMATELY 0.2 CC) PROBABLY WAS FROM THE FRACTURE LINE WHICH EXISTED BEFORE OPERATION. LEAKAGE STOPPED AROUND ANTERIOR LONGITUDINAL LIGAMENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8068300 ↗

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-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
• 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