CONFIDENCE SPINAL CEMENT SYSTEM 283905000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034209555), received between Mar 9, 2020 and Jul 25, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Chemical Problem; Chemical Problem

  ADDITIONAL INFORMATION RECEIVED: A. HOW WAS THE CEMENT PREPARED FOR USE? - PER INSTRUCTIONS IN IFU. B. WHAT EQUIPMENT WAS USED TO PREPARE / MIX THE CEMENT? - COMPONENTS WITHIN KIT USED TO MIX CEMENT AS ALWAYS. C. WHAT WAS THE TIMING TO MIX AND THE TIME BETWEEN MIXING AND SETTING? - CEMENT WAS MIXED ACCORDING TO INSTRUCTIONS BETWEEN 35 AND 40 SECONDS AND THIS IS WHERE IT WAS NOTED THAT THE CONSISTENCY WAS DIFFERENT THAN SEEN IN PREVIOUS CASES. D. WHAT EQUIPMENT WAS USED TO DELIVER THE CEMENT? - CEMENT WAS NOT DELIVERED, JUST ATTEMPTED MIXING. E. CAN YOU PROVIDE THE QUANTITY USED OF THE CEMENT PRODUCT? - NONE OF THIS KIT WAS USED DUE TO THE IDENTIFIED IN CONSISTENCY AFTER MIXING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613489 ↗
• MalfunctionNov 6, 2023Appropriate Device Problem Term/Code Not Available; Inaccurate Information; Appropriate Device Problem Term/Code Not Available; Inaccurate Information

  IT WAS REPORTED THAT THE CEMENT SYSTEM IN QUESTION HAD TWO DIFFERENT EXPIRATION DATES. THE STICKER ON THE OUTSIDE OF THE BOX HAS AN EXPIRATION DATE OF 30-SEPTEMBER-2023 AND ALL ITEMS INSIDE THE BOX HAD EXPIRATION DATES WITH THE EARLIEST OF SEPTEMBER-2024. THE TWO CONFLICTING EXPIRATIONS CAUSED QUESTION ABOUT THE USE OF THE PRODUCT. IT WAS NOT USED ON THE PATIENT. A NEW 5CC CEMENT KIT FROM DEPUY SYNTHES WAS OPENED AND THERE WERE DISRUPTIONS/SAFETY EVENTS RECORDED. ALL MATERIALS HAVE BEEN RETAINED AND CAN BE SENT BACK. THE PROCEDURE DURING WHICH THIS ISSUE WAS DISCOVERED WAS COMPLETED SUCCESSFULLY, ANOTHER CEMENT KIT WAS USED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE KIT SPINAL CEMENT SYSTEM 5CC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074079 ↗
• MalfunctionMar 22, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON FEBRUARY 28, 2023, UPON OPENING A LARGE CONFIDENCE CEMENT KIT AND FOLLOWING THE PRECISE MIXING INSTRUCTIONS, THE CEMENT SEEMED TO HARDEN AND WHEN ATTACHING THE VIAL THAT IS SUPPOSED TO FILL WITH CEMENT, THE VIAL DID NOT FILL AND THE CEMENT APPEARED STILL GRAINY INSTEAD OF SMOOTH. A SECOND LARGE CONFIDENT FROM THE SAME LOT. AGAIN, THE SAME ISSUE OCCURRED WHERE THE VIAL DID NOT FILL AND THE CEMENT LOOKED INCORRECT. ALL INGREDIENTS WERE MIXED AS MEASURED AND TIMED WHEN MIXING. LASTLY, WE OPENED A HALF DOSE 5CC CONFIDENCE KIT, AND THE GOAL OF LIQUID WAS BROKEN AND UNUSABLE. NO CONTACT WAS MADE WITH PATIENT. THE SURGERY WAS SURGERY WAS SUCCESSFULLY COMPLETED WITH SURGICAL DELAY OF 20 MINUTES. THIS COMPLAIN INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) CONFIDENCE HALF DOSE KIT (5CC) THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592977 ↗
• MalfunctionAug 16, 2022Migration or Expulsion of Device; Failure to Eject; Migration or Expulsion of Device; Failure to Eject

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE PUMPS LIMP (METAL) WAS UNABLE TO PROPERLY CLAMP TO THE SERINGUE CEMENT CAP END- THIS CAUSED HYDRAULIC PRESSURE AND THE STERILE WATER WAS LEAKING. THEY SIMPLY PLACED THE ENTIRE KIT ASIDE AND USED ANOTHER 5CC CONFIDENCE CEMENT. NO MAJOR DELAYS AS PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NOT IMPACTED BY THIS. THIS REPORT IS FOR ONE (1) CONFIDENCE HALF DOSE KIT (5CC) THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234971 ↗
• MalfunctionFeb 16, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED INTRA-OPERATIVELY, DURING THE INSERTION OF THE CEMENT, THE CEMENT SEEMED TO PROTRUDE ANTERIORLY. AFTER THE INTRODUCTION OF THE CEMENT AN AP AND LAT FLUORO-IMAGING WAS TAKEN TO CONFIRM THAT THE CEMENT HAD STAYED WITH THE BORDERS OF THE VERTEBRAL BODY. THIS REPORT IS FOR A CONFIDENCE CEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13542102 ↗
• MalfunctionMar 9, 2020Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A KYPHOPLASTY CASE WITH A CONFIDENCE CEMENT KIT, THE CEMENT DID NOT CONNECT TO THE PORT THAT HOLDS THE CEMENT AFTER MIXING. THE CEMENT KIT MIXING CEMENT WAS EXTREMELY HARD TO THE POINT, MAKING IT IMPOSSIBLE TO TRANSFER. THREE (3) MORE CEMENT KITS WERE USED AND UNSPECIFIED ISSUES OF NOT BEING ABLE TO CONNECT OCCURRED AGAIN. THE PROCEDURE AND PATIENT STATUS IS UNKNOWN. SURGICAL DELAY IS UNKNOWN. CONCOMITANT DEVICES REPORTED: CONFIDENCE HALF DOSE KIT (5CC) (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 4). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9805663 ↗

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-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-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-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.