CONFIDENCE SPINAL CEMENT SYSTEM 283902611Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034209432), received between Oct 4, 2018 and Dec 31, 2024 — classified as 4 injuries, 2 malfunctions.

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

• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON (B)(4) 2024. OVER THE FOLLOWING WEEKEND, THE PATIENT PRESENTED WITH AN INFECTION. PATIENT HAD BEEN IMPLANTED WITH TRIALTIS THORACOLUMBAR SYSTEM. IN ADDITION TO IMPLANTING TRIALTIS, THE SURGEON USED CONFIDENCE BONE CEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 21048365 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2024. OVER THE FOLLOWING WEEKEND, THE PATIENT PRESENTED WITH AN INFECTION. PATIENT HAD BEEN IMPLANTED WITH TRIALTIS THORACOLUMBAR SYSTEM. IN ADDITION TO IMPLANTING TRIALTIS, THE SURGEON USED CONFIDENCE BONE CEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 21035837 ↗
• MalfunctionAug 22, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A REVISION SURGERY ON (B)(6) 2024, A CEMENTED SCREW WAS REMOVED AND THE TROCAR WAS USED TO INSERT ADDITIONAL CEMENT. THE TROCAR WAS LEFT INSIDE THE CEMENT TOO LONG AND WHEN THE SURGEON TRIED TO REMOVE IT, ABOUT 4 CM OF THE TROCAR REMAINED IN THE VERTEBRAL BODY, SURROUNDED BY CEMENT AND WITH CEMENT INSIDE. THE SURGERY WAS DELAYED BY 30 MINUTES DUE TO THE EVENT. THE PATIENT OUTCOME WAS REPORTED TO BE GOOD, WITHOUT COMPLICATIONS. IT WAS REPORTED THAT THE REVISION WAS DUE TO INFECTION OF THE PREVIOUS AUGMENTED SCREWS SYSTEM. A SCREW REMOVAL WAS PLANNED AND CEMENT WAS INSERTED INSTEAD OF SCREWS. THIS REPORT INVOLVES ONE CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, BEVELED TIP 11G X 6 INCHES THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES THE REPORTED INFECTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20031397 ↗
• MalfunctionMar 30, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR SPINAL FUSION PERFORMED ON (B)(6) 2022. THE BONE QUALITY WAS VERY HARD, AND THE NEEDLES WERE FORCEFULLY INSERTED. WHEN THE NEEDLES WERE REMOVED, SIGNIFICANT FORCE WAS REQUIRED TO REMOVE THE NEEDLES. THE NEEDLES WERE REMOVED BY USING PLIERS AND HAMMERS. ONE WAS DISASSEMBLED AND HAD A T-HANDLE THAT CAME OFF. ONE WAS DEFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CONF INTRO NDLE, BEV, 11G 6". THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645384 ↗
• InjuryOct 4, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018 THE SURGEON WAS USING (B)(4) AND THE SURGEON TWISTED IT AND IT BECAME APPARENT THERE WAS A PROBLEM. THE NEEDLE THEN BROKE INSIDE THE PATIENT AND MY UNDERSTANDING IS THAT THE NEEDLE HAD TO BE LEFT THERE. THERE WERE TWO NEEDLES INVOLVED WITH THE SAME PRODUCT CODE BUT THEY HAD DIFFERENT LOT NUMBERS ¿ HTHBFK AND 184350.

  Patient problems: Foreign Body In Patient

  MAUDE report 7935871 ↗
• InjuryOct 4, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018 THE SURGEON WAS USING (B)(4) AND THE SURGEON TWISTED IT AND IT BECAME APPARENT THERE WAS A PROBLEM. THE NEEDLE THEN BROKE INSIDE THE PATIENT AND MY UNDERSTANDING IS THAT THE NEEDLE HAD TO BE LEFT THERE. THERE WERE TWO NEEDLES INVOLVED WITH THE SAME PRODUCT CODE BUT THEY HAD DIFFERENT LOT NUMBERS ¿ HTHBFK AND 184350.

  Patient problems: Foreign Body In Patient

  MAUDE report 7935839 ↗