EIT ALIF cage AUI10840Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260557772751), received between Jan 11, 2022 and Jan 11, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (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 18, 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.

• MalfunctionJan 11, 2022Inaccurate Information; Inaccurate Information

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE INSTRUCTIONS FOR USE (IFU) FOR THE CONDUIT ALIF IMPLANTS MARKS THE IMPLANTS WHICH ONLY HAVE THE ANTERIOR INSERTER INTERFACE CONNECTION WITH A FOOTNOTE SYMBOL. FOR A SURGERY THE SURGEON SELECTED A SIZE L 8MM 5° IMPLANT BECAUSE THE IFU SHOWS THE IMPLANT WITHOUT A FOOTNOTE SYMBOL. THE SURGEON STATES THAT THIS IMPLANT SHOULD ALSO HAVE THE LATERAL INSERTER INTERFACE. SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER AVAILABLE IMPLANT. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THIS REPORT INVOLVES ONE (1) EIT ALIF, H 8MM, 5°, L. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13227983 ↗