CONFIDENCE SPINAL CEMENT SYSTEM 283913000Recalls & reported problems

Summary

The FDA's MAUDE database contains 146 adverse event reports that list this exact device (DI 10705034209630), received between Aug 1, 2017 and Sep 30, 2026 — classified as 8 deaths, 5 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (43 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 146 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Chemical Problem

  It was reported that the cement was very tough, could not be mixed as described in the packaging instructions. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948790 ↗
• MalfunctionSep 21, 2026Migration or Expulsion of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841885 ↗
• MalfunctionSep 9, 2026Break; Migration or Expulsion of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698204 ↗
• MalfunctionMay 15, 2026Migration or Expulsion of Device

  IT WAS REPORTED THE CONFIDENCE CEMENT PUMP LEAKED INSTEAD OF PROPELLING CEMENT NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183840 ↗
• MalfunctionFeb 26, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT FLUID FROM THE PUMP HAS BEEN LEAKING DURING THE APPLICATION OF CEMENT TO THE SCREWS INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24460857 ↗
• MalfunctionFeb 26, 2026Crack

  IT WAS REPORTED THAT ON FEBRUARY 13, 2026, THE CEMENT MIXING BOWL CRACKED WHEN THE BOX WAS OPENED. THERE WERE NO REPORTED PATIENT CONSEQUENCES. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456643 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT THE PUMP SYSTEM HAS BURST. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399904 ↗
• MalfunctionFeb 9, 2026Chemical Problem

  IT WAS REPORTED THAT CONFIDENCE KIT, NO NEEDLES, EXPERIENCED A FAILURE IN WHICH THE CEMENT BECAME LUMPY AFTER MIXING, RESULTING IN AN INABILITY TO MIX THE CEMENT PROPERLY. THE EVENT OCCURRED INTRA-OPERATIVELY. THE PATIENT DID NOT COME INTO CONTACT WITH THE PRODUCT, AND THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. SURGERY WAS PROLONGED BY EIGHT MINUTES, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER A NEW ITEM WAS OPENED. NO FRAGMENTS WERE GENERATED, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292004 ↗
• MalfunctionFeb 6, 2026Chemical Problem

  IT WAS REPORTED THAT THE CEMENT WAS LUMPY AFTER MIXING. THE PATIENT DID NOT COME INTO CONTACT WITH THE PRODUCT, AND NO ADDITIONAL MEDICAL INTERVENTIONS REQUIRED. THERE WAS A SURGICAL DELAY OF EIGHT (8) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY OPENING A NEW ITEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279768 ↗
• MalfunctionJan 22, 2026Chemical Problem

  IT WAS REPORTED THAT DURING AN INTRA-OPERATIVE EVENT, AFTER MIXING THE REAGENTS, THE CEMENT DID NOT ACHIEVE THE CORRECT CONSISTENCY, WAS NOT SMOOTH, AND REMAINED IN THE MIXER. THE EVENT WAS DESCRIBED AS THE INABILITY TO MIX THE INGREDIENTS EFFECTIVELY, WITH LUMPS FORMING IN THE MIXTURE. THERE WAS NO PATIENT INVOLVEMENT OR CONSEQUENCE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A GOOD OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146260 ↗
• 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 24057166 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT THE GLASS IN THE PACK BROKE PRIOR TO MIXING DURING A SPINAL FUSION SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY AND WITHOUT PATIENT CONSEQUENCE. NO FRAGMENTS WERE GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379656 ↗
• MalfunctionAug 27, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER FILLING THE 2 SCREW, THERE IS FLUID IN THE ROTATING HANDLE AND IN THE CEMENT. THIS IS MOST LIKELY THE HYDRAULIC FLUID FROM THE APPLICATION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902273 ↗
• MalfunctionAug 7, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THERE WAS A LEAK IN THE LOWER COLUMN. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742526 ↗
• MalfunctionAug 1, 2025Break; Break

  IT WAS REPORTED THAT THE LOWER PART EXPLODED AND THE PRESSURE GUN DISINTEGRATED. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687001 ↗
• MalfunctionJul 31, 2025Chemical Problem; Chemical Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A POSTOPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676317 ↗
• MalfunctionJul 31, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A VERTEBROPLASTY, HYDRAULIC FLUID LEAKED FROM THE CONNECTION WITH THE CEMENT RESERVOIR WHILST IN USAGE. SURGERY WAS DELAYED BY TEN MINUTES DUE TO THE EVENT AND WAS SUCCESSFULLY COMPLETED WITH A NEW CONFIDENCE CEMENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674266 ↗
• MalfunctionJul 16, 2025Chemical Problem; Chemical Problem

  IT WAS REPORTED BY THE PHYSICIAN THAT AFTER MIXING THE CEMENT, THE CONSISTENCY WAS INCORRECT, THE CEMENT WEIGHED. TO COMPLETE THE PROCEDURE, THE PHYSICIAN USED ANOTHER SAME TYPE PRODUCT. NO CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521014 ↗
• MalfunctionJul 16, 2025Chemical Problem; Chemical Problem

  IT WAS REPORTED BY THE PHYSICIAN THAT AFTER MIXING THE CEMENT, THE CONSISTENCY WAS INCORRECT, THE CEMENT WEIGHED. TO COMPLETE THE PROCEDURE, THE PHYSICIAN USED ANOTHER SAME TYPE PRODUCT. NO CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521000 ↗
• MalfunctionJun 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE CEMENTING OF A LUMBAR SCREW, WITH CONFIDENCE CEMENT, THE HYDRAULIC PUMP STARTED LEAKING, AND THE WATER CAME OUT BEHIND THE SEALING RING. THE SAME PROBLEM OCCURRED THE WEEK BEFORE. THIS TIME, IT OCCURRED WITH TWO CONFIDENCE IN A ROW, IT WORKED ONLY IN THE THIRD PACK. SURGERY WAS DELAYED BY 20 MINUTES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157523 ↗
• MalfunctionJun 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE CEMENTING OF A LUMBAR SCREW, WITH CONFIDENCE CEMENT, THE HYDRAULIC PUMP STARTED LEAKING, AND THE WATER CAME OUT BEHIND THE SEALING RING. THE SAME PROBLEM OCCURRED THE WEEK BEFORE. THIS TIME, IT OCCURRED WITH TWO CONFIDENCES IN A ROW, IT WORKED ONLY IN THE THIRD PACK. SURGERY WAS DELAYED BY 20 MINUTES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157521 ↗
• MalfunctionMay 29, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT CONFIDENCE CEMENT PUMPED LEAKED INTRAOPERATIVELY. IT WAS UNKNOWN IF THE SURGERY WAS DELAYED OR COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107396 ↗
• MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE CEMENTING OF A LUMBAR PEDICLE SCREW WITH CONFIDENCE CEMENT, THE HYDRAULIC PUMP BECAME LEAKING, AND THE WATER CAME OUT BEHIND THE SEALING RING. THERE WAS NO PATIENT CONSEQUENCE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096883 ↗
• MalfunctionMay 23, 2025Migration or Expulsion of Device; Chemical Problem; Migration or Expulsion of Device; Chemical Problem

  IT WAS REPORTED THAT WHILE INSERTING THE CEMENT INTO THE FIRST SCREW, THE BACK PART OF THE SYRINGE WITH THE PISTON CAME OFF. AS A RESULT, THE CANNULA WAS ALSO DAMAGED BECAUSE THE CEMENT INSIDE HARDENED. IT WAS NOTED THAT ONCE THEY STARTED SCREWING, AFTER THE FIRST TURN, THE SYRINGE COLLAR, COLLAPSED AND THE LIQUID CONTAINED WITHIN IT CAME OUT. THE INTERNAL GEAR (THE PRESSURE GEAR) BROKE. A SECOND SET WAS OPENED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078965 ↗
• MalfunctionMay 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LEAKAGE FROM THE WATER PUMP DURING THE PROCEDURE. PHYSICIAN USED ANOTHER PRODUCT OF THE SAME TYPE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027587 ↗

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-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-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-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-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.
• 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.