AEGIS 287110100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034218144), received between Mar 10, 2023 and Mar 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionMar 10, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT ONE OF THE INSTRUMENTS RECEIVED IN THE CONDUIT AEGIS SET WAS DAMAGED. THE TIP OF THE VARIABLE AWL WAS DENTED AND HAS A BURR. THERE WAS PATIENT AND PROCEDURE INVOLVEMENT, BUT THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE AEGIS ANTERIOR LUMBAR PLATE AWL, VARIABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522000 ↗