CONFIDENCE SPINAL CEMENT SYSTEM 283999002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034462479), received between Jan 31, 2023 and Jan 31, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, A CEMENT OCCURRED LEAK IN THE CANAL, LEFT SIDE, DURING L1 KYPHOPLASTY.MATERIAL USED : 4.7MM ACCESS KIT. THE SURGERY WAS DELAYED BY 90 MINUTES DUE TO THE EVENT. THE SURGEON PERFORMED A LAMINECTOMY, DECOMPRESSION, AND PARTIAL CEMENT REMOVAL IN RESPONSE TO THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, BUT BITS AND PIECES OF THE CEMENT REMAINED IN THE CANAL. PATIENT IS FINE, NO CONSEQUENCES. THIS REPORT IS FOR ONE (1) LUER ADAPTOR CONF CEMENT-PK/10. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16274263 ↗