CONFIDENCE SPINAL CEMENT SYSTEM 283910000Recalls & reported problems

Summary

The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 10705034209623), received between Aug 15, 2017 and Sep 24, 2026 — classified as 5 deaths, 21 injuries, 137 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (62 reports).

8 other recalls cover devices cleared under the same FDA submission (K060300); 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 25 most recent of 163 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Migration or Expulsion of Device; Failure to Eject

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885539 ↗
• MalfunctionSep 22, 2026Migration or Expulsion of Device

  It was reported that when using Confidence granulation, both stirring and assembly during the procedure went smoothly. Bone cement was poured in, and the rotary pressure doctor felt no pressure and noticed the milk bottle was leaking. They immediately requested a mobile video and urgently contacted the supervisor, deciding to reapply a new CONFIDENCE pack. The surgery was successfully completed with the defective product retained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859061 ↗
• MalfunctionSep 2, 2026Migration or Expulsion of Device; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572833 ↗
• MalfunctionSep 2, 2026Migration or Expulsion of Device; Failure to Eject

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564156 ↗
• MalfunctionMay 18, 2026Chemical Problem; Failure to Eject

  DURING THE VERTEBROPLASTY PROCEDURE, THE BONE CEMENT (CONFIDENCE KIT) WAS OPENED AND PREPARED. AT THE TIME OF TRANSFERRING THE PRODUCT TO THE APPLICATION SYSTEM, SIGNIFICANT DIFFICULTY WAS OBSERVED, AND AN INCREASE IN VISCOSITY WAS IDENTIFIED THAT WAS INCOMPATIBLE WITH THE APPROPRIATE HANDLING PHASE. IN VIEW OF THE IMPOSSIBILITY OF USING THE PREPARED MATERIAL, IT WAS DISCARDED ACCORDING TO THE GUIDANCE OF THE HOSPITAL INSTITUTION. THERE WAS NO DAMAGE REPORTED BY THE PATIENT OR USER. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25202086 ↗
• MalfunctionApr 22, 2026Chemical Problem

  INSUFFICIENT MIXING LIQUID: AFTER OPENING THE BOTTLE AND STIRRING, IT CANNOT BE MIXED EVENLY; SOME CEMENT REMAINS IN POWDER FORM. ONLY HALF THE NORMAL USAGE AMOUNT IS SQUEEZED INTO THE BOTTLE. A NEW BOTTLE WAS USED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957902 ↗
• MalfunctionMar 6, 2026Migration or Expulsion of Device; Failure to Eject

  IT WAS REPORTED THAT WHEN THE BONE CEMENT WAS HALFWAY POURED IN, WATER STARTED LEAKING FROM THE CAP. THE CAP WAS CHECKED AND FOUND TO BE SECURELY LOCKED. THE DOCTOR CONTINUED TO TURN THE PRESSURE GUN, BUT WATER BEGAN SPRAYING OUT OF THE CAP. BECAUSE TOO MUCH WATER WAS BEING LOST FROM THE PRESSURE GUN, THE BONE CEMENT COULD NOT BE POURED IN FURTHER, AND THE ATTENDING PHYSICIAN REQUESTED ANOTHER PACKET. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533483 ↗
• MalfunctionJan 23, 2026Pressure Problem

  IT WAS REPORTED THAT CONFIDENCE SPINAL CMT SYS, 11C WAS INVOLVED IN AN INTRAOPERATIVE EVENT. DURING PREPARATION AND CEMENT INJECTION, THE PHYSICIAN NOTED A LACK OF RESISTANCE AND DISCOVERED THAT STERILE WATER WAS INSIDE THE CEMENT. FURTHER INSPECTION REVEALED THE BLACK CAP, WHICH IS TYPICALLY FACTORY-INSERTED AND NOT MANIPULATED DURING THE PROCEDURE, HAD COME LOOSE, RESULTING IN THE OBSERVED ISSUE. ALL PROCEDURAL STEPS WERE FOLLOWED ACCORDING TO THE SURGICAL TECHNIQUE, AND THE EVENT DID NOT AFFECT THE PATIENT OR ALTER SURGICAL TIMES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164017 ↗
• MalfunctionJan 13, 2026Migration or Expulsion of Device; Failure to Eject

  THE THRUSTER JOINT IS LEAKING, AND THE PRESSURE IS NOT HIGH ENOUGH TO PUSH THE CEMENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24057139 ↗
• MalfunctionDec 30, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY IN RELATION TO THE REPORTED EVENT? DELAYED AROUND 3 MINUTES, OPEN A NEW ONE TO FINISH THE SURGERY. B. WAS THE SURGERY COMPLETED SUCCESSFULLY? (YES OR NO): YES, IT IS FINISHED WITH A NEW PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922881 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED WHILE FILLING CONFIDENCE CEMENT SYSTEM, IT RUPTURED. A NEW ONE WAS USED TO COMPLETE THE PROCEDURE WITH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888476 ↗
• MalfunctionDec 8, 2025Break; Failure to Eject; Break; Failure to Eject

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE PUNCTURE NEEDLE REACHED THE T11 AND T12 POSITIONING POINTS, THE REMAINING TOOLS FOR THE KANGFU BONE CEMENT WERE APPLIED. THE POWDER AND LIQUID WERE POURED INTO THE MIXING BOX AND STIRRED FOR ABOUT 40-50 SECONDS BEFORE FILLING. THE PUNCTURE NEEDLE WAS THEN TIGHTENED TO THE MAXIMUM BEFORE THE BONE CEMENT WAS INJECTED. WHEN ROTATING THE PRESSURE GUN, THE GASKET IN THE TRANSPARENT BOTTLE DID NOT ADVANCE. WATER BEGAN TO SLOWLY SPRAY FROM THE INTERFACE BETWEEN THE WATER GUN AND THE TRANSPARENT BOTTLE. THE ASSEMBLY WAS RECHECKED AND REINSTALLED, AND THE WATER GUN WAS ROTATED AGAIN. WATER WAS SPRAYED FROM THE METAL RING AT THE WATER GUN CONNECTOR. EVEN WITH THE INTERFACE FIRMLY HELD, THE GASKET IN THE BOTTLE STILL ONLY ADVANCED SLOWLY, PUSHING THE CEMENT INTO THE VERTEBRAL BODY. AFTER INJECTING 5CC INTO T11, ALL THE WATER IN THE GUN HAD LEAKED OUT, MAKING IT IMPOSSIBLE TO INJECT INTO T12. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745003 ↗
• MalfunctionOct 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE GLASS BOTTLE WAS NOT FILLED ALL THE WAY, IT IS ONLY 5CC, WHICH IS LESS THAN THE ORIGINAL 11CC. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369856 ↗
• MalfunctionOct 6, 2025Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED WHILE USING THE CONFIDENCE GROUTING SYSTEM, THE MIXING AND ASSEMBLY PROCESS WENT SMOOTHLY DURING THE PROCEDURE. AS THE SURGEON BEGAN POURING THE BONE CEMENT, FEELING THE PRESSURE GRADUALLY DECREASE, HE NOTICED A LEAK IN THE MILK BOTTLE. HE IMMEDIATELY DISASSEMBLED AND REASSEMBLED IT, ONLY TO DISCOVER A BROKEN GASKET HAD FALLEN OUT. AFTER REASSEMBLY, THE LEAK PERSISTED. DUE TO TIME PRESSURE, THE BONE CEMENT HAD ALREADY HARDENED, SO HE URGENTLY CONTACTED HIS SUPERVISOR, WHO THEN ALLOWED HIM TO OPEN ANOTHER PACKAGE AND USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23227866 ↗
• MalfunctionSep 23, 2025Migration or Expulsion of Device; Failure to Eject; Migration or Expulsion of Device; Failure to Eject

  IT WAS REPORTED THAT DURING THE PVP SURGERY, DURING THE CONNECTION OF CONFIDENCE HIGH VISCOSITY SPINAL CEMENT KIT, AIR LEAKAGE AND WATER LEAKAGE OCCURRED AT THE JOINT OF THE PRESSURE PUMP AND THE ADAPTER CONNECTED WITH THE CEMENT, RESULTING IN THAT THE CEMENT COULD NOT BE INJECTED NORMALLY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23123711 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THE CONFIDENCE CEMENT KIT WAS OPENED AND THE BIOPSY NEEDLE WAS OBSERVED BENT. A NEW KIT WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO DELAY OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006197 ↗
• MalfunctionSep 9, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, WHEN USING THE SECOND KIT, IT WAS FOUND THAT THE PLUNGER WAS POSITIONED INAPPROPRIATELY, PREVENTING THE CEMENT FROM LEAVING AND PREVENTING ITS USE IN THE SECOND VERTEBRA. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED SECOND DEVICE IT WAS IDENTIFIED THAT THE PARTS OF THE KIT ARE BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 23005886 ↗
• MalfunctionSep 9, 2025Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, WHEN USING THE SECOND KIT, IT WAS FOUND THAT THE PLUNGER WAS POSITIONED INAPPROPRIATELY, PREVENTING THE CEMENT FROM LEAVING AND PREVENTING ITS USE IN THE SECOND VERTEBRA. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE CRYSTAL TUBE WAS BROKEN FROM THE THREADS ON THE PROXIMAL END, ALSO IT WAS FILLED WITH CEMENT, HOWEVER, PLUNGER WAS POSITIONED IN THE TUBE BEFORE THE CEMENT, IN CONSEQUENCE, BLOCKING THE FLOW OF MIXTURE.

  Patient problems: Insufficient Information

  MAUDE report 23005868 ↗
• MalfunctionSep 5, 2025Fluid/Blood Leak; Failure to Eject; Fluid/Blood Leak; Failure to Eject

  IT WAS REPORTED THAT THE CONFIDENCE CEMENT WAS USED TO FILL L3. THE MIXING AND ASSEMBLY PROCESS WENT SMOOTHLY DURING THE OPERATION. AFTER POURING 2ML OF BONE CEMENT, THE DOCTOR FELT THE PRESSURE DECREASING AND DISCOVERED THAT THE MILK BOTTLE WAS LEAKING AGAIN. AFTER REASSEMBLY, IT WAS STILL LEAKING. THE BONE CEMENT COULD NO LONGER BE PRESSURIZED. AFTER URGENTLY CONTACTING THE SUPERVISOR, THE DOCTOR WAS ALLOWED TO OPEN ANOTHER BAG FOR USE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976099 ↗
• MalfunctionSep 3, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  ADDITIONAL INFORMATION RECEIVED: A; WAS THERE ANY ALLEGATION AGAINST THE CEMENT? NONE. B. HOW WAS THE CEMENT PREPARED FOR USE? PER TECH GUIDE. C. WHAT EQUIPMENT WAS USED TO PREPARE / MIX THE CEMENT? THE MIXING WELL FROM THE KIT. D. WHAT WAS THE TIMING TO MIX AND THE TIME BETWEEN MIXING AND SETTING? THE CEMENT WAS MIXED FOR ONE MINUTE, ATTACHED TO THE HYRAUDLIC PUMP, AND HANDED UP TO THE FIELD FOR USE. E. WHAT EQUIPMENT WAS USED TO DELIVER THE CEMENT? AN OPEN CANNULA THROUGH A VERSE ALIGNMENT GUIDE AND SCREW. F. CAN YOU PROVIDE THE QUANTITY USED OF THE CEMENT PRODUCT? 10CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952257 ↗
• MalfunctionAug 26, 2025Migration or Expulsion of Device; Failure to Eject; Migration or Expulsion of Device; Failure to Eject

  IT WAS REPORTED THE CEMENT WAS PREPARED AND AT THE TIME OF INJECTING IT THROUGH THE CEMENTING CANNULAS, IT WAS NOTICED THAT THE CEMENT IS NOT GOING DOWN. THE PUMP WAS CHECKED AND IT IS SCREWED PROPERLY ONTO THE PIPETTE, IT IS NOT GOING DOWN. AN ATTEMPT IS MADE TO INJECT AGAIN, BUT IT DOES NOT GO DOWN TO THE POINT THAT THE PRESSURE INCREASES AND WATER BEGINS TO LEAK THROUGHOUT THE PUMP MECHANISM. THIS CAUSES THE CEMENT TO REMAIN INSIDE THE PIPETTE AND CANNOT BE INJECTED, SETTING IN ITS ESTABLISHED TIME. THE 10CC OF CEMENT ARE LOST AND IT CANNOT BE USED. THE OTHER KIT THAT THEY SENT MUST BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897846 ↗
• MalfunctionJul 8, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT WHEN THE WATER PUMP TURNED OVER TO RELEASE THE PRESSURE DURING THE OPERATION, THE WHITE COVER ON THE WATER PUMP IS ALSO TURNED OUT (IT NEEDS TO BE LOCKED BACK BY USING INSTRUMENT/TOOL), RESULTING IN THE SUBSEQUENT LOSS OF PRESSURE AND INABILITY TO CONTINUE PRESSURIZING CEMENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440304 ↗
• MalfunctionJul 8, 2025Pressure Problem; Pressure Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT POST-OP FEEDBACK WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440094 ↗
• MalfunctionJul 2, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER THE INTRAOPERATIVE PUNCTURE NEEDLE WAS POSITIONED, THE BONE MUD WAS ASSEMBLED. THE PUNCTURE NEEDLE WAS LOCKED AS TIGHT AS POSSIBLE BEFORE THE BONE MUD WAS POURED IN. WHEN THE PRESSURE GUN WAS ROTATED, LESS THAN 1CC OF BONE MUD WENT IN AND WATER KEPT FLOWING OUT OF THE BOTTLE. THE ASSEMBLY WAS RE-CHECKED AND INSTALLED AGAIN AND WAS PRESSED TO POUR IN LESS THAN 2CC. THERE WAS STILL WATER LEAKAGE AT THE JOINT. THE SUPERVISOR AND THE DOCTOR REPEATED THE TEST OF THE ASSEMBLY AND TESTED OUT ALL THE WATER. THEN SALES REP IMMEDIATELY PUT IN ANOTHER BOX AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386675 ↗
• MalfunctionJul 2, 2025Migration or Expulsion of Device; Failure to Eject; Migration or Expulsion of Device; Failure to Eject

  IT WAS REPORTED THAT THERE IS PRESSURE WHEN THE GROUTING STARTS. WHEN THE PRESSURE IS RELEASED AND THE CAR IS REVERSED, THE WHITE COVER ON THE PROPELLER AND THE T HANDLE ARE SEPARATED TOGETHER, AND THE CEMENT DOES NOT RELEASE PRESSURE AND EXIT. THE PRESSURE FORCES THE CEMENT TO CONTINUE TO FLOW INTO THE BODY. IT WAS CHANGED TO THE NEW ONE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386276 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060300. One submission often covers many models, so check the product and lot details in each record.

• Z-1300-2018 · Dec 15, 2017 · Terminated
  Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM 11cc Kit
• Z-2132-2013 · Apr 17, 2013 · Terminated
  CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is
• Z-2134-2013 · Apr 17, 2013 · Terminated
  CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is in
• Z-2133-2013 · Apr 17, 2013 · Terminated
  CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, wh
• Z-0963-2013 · Jan 15, 2013 · Terminated
  DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
• Z-0962-2013 · Jan 15, 2013 · Terminated
  DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
• Z-0961-2013 · Jan 15, 2013 · Terminated
  DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
• Z-0960-2013 · Jan 15, 2013 · Terminated
  DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.