EIT CIF Trial CET2870SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04260397081617), received between Aug 18, 2021 and Feb 28, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K170503); 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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 28, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, THE HANDLE FOR TRIAL BROKE AT THE NECK, LEAVING THE TRIAL HEAD IN THE PATIENT'S DISC SPACE. THE CASPAR PINS WERE INSERTED TO OPEN THE DISC SPACE AND THE TRIAL HEAD WAS RETRIEVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH TEN(10) MINUTES OF SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) TRIAL H 7MM 8DEG S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455655 ↗
• MalfunctionAug 18, 2021Break; Break

  IT WAS FURTHER REPORTED THAT THERE WAS AN UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340209 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170503. One submission often covers many models, so check the product and lot details in each record.

• Z-1324-2022 · May 20, 2022 · Open, Classified
  EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD
• Z-1323-2022 · May 20, 2022 · Open, Classified
  EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD