CoRoent 5485540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517250193), received between Jan 25, 2024 and Jan 25, 2024 — classified as 2 malfunctions.

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

• MalfunctionJan 25, 2024Migration; Migration

  ON (B)(6) 2023 A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION AT L2/3. ON (B)(6) 2024 THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE SCREWS BECOMING LOOSE (200073943) AND CAGE MIGRATION (200073944). THE SURGEON REMOVED THEM AND TAMPED THE CAGE IN. HE ALSO EXTENDED UP TWO LEVELS. NO ADDITIONAL INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18583729 ↗
• MalfunctionJan 25, 2024Migration; Migration

  ON (B)(6), 2023 A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION AT L2/3. ON (B)(6) 2024 THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE SCREWS BECOMING LOOSE ((B)(6)) AND CAGE MIGRATION ((B)(6)). THE SURGEON REMOVED THEM AND TAMPED THE CAGE IN. HE ALSO EXTENDED UP TWO LEVELS. NO ADDITIONAL INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18583500 ↗