CONFIDENCE SPINAL CEMENT SYSTEM 283902613Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034209449), received between Mar 11, 2019 and Aug 25, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A VERTEBROPLASTY OF A METASTASIZED VERTEBRAL BODY IN A (B)(6) YEAR-OLD TUMOR PATIENT, THE HANDLE OF THE CONFIDENCE NEEDLE BROKE WHEN TRYING TO REMOVE IT AFTER THE CEMENT APPLICATION. THE SHAFT GOT STUCK IN THE PATIENT AND COULD ONLY BE REMOVED WITH THE HELP OF FORCEPS, THE ASSISTANCE OF AN ACCIDENT SURGEON, CONSIDERABLE ADDITIONAL EXPENDITURE OF TIME AND RADIATION EXPOSURE FOR THE PATIENT. THERE WAS A SURGICAL DELAY OF FORTY-FIVE (45) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, BEVELED TIP 13G X 6 INCHES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 10448117 ↗
• MalfunctionMar 11, 2019Break; Break

  IT WAS REPORTED THAT THE END OF NEEDLE TORE DURING USE. NO PATIENT IMPACT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, ACTION TAKEN WHEN EVENT OCCURRED? --> NEW NEEDLE USED, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8408874 ↗