CoRoent 6980845Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887517402998), received between May 17, 2017 and Sep 8, 2023 — classified as 1 death, 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CAGE FRACTURED WHILE IT WAS BEING IMPACTED INTO THE DISC SPACE. REPORTEDLY, THE CAGE WAS BEING DRIVEN INTO THE DISC SPACE CORRECTLY AND IN A COMPLETELY STRAIGHT MANNER. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17716287 ↗
• MalfunctionOct 10, 2018Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  ON (B)(6) 2015 PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE. ON (B)(6) 2018 IT WAS REPORTED MIGRATION OF CAGE, FATIGUE/FRACTURE WAS NOTED. NO INFORMATION IN REGARDS TO A REVISION PROCEDURE HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7953997 ↗
• MalfunctionOct 10, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2015 PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE. ON (B)(6) 2018 MIGRATION OF CAGE AND SUBSIDENCE WAS REPORTED. NO REVISION PROCEDURE HAS BEEN SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 7953855 ↗
• InjuryJul 18, 2018Break; Fracture; Break; Fracture

  ON (B)(6) 2018 WHILE PLACING A COROENT XL CAGE, ALLEGEDLY CAGE FRACTURED RESULTING IN AN UNSPECIFIED VENOUS INJURY. NO OTHER INFORMATION HAS BEEN PROVIDED. IT IS UNKNOWN IF PRODUCT WAS REMOVED FROM PATIENT NOR IF PROCEDURE CONTINUED.

  Patient problems: Blood Loss; Patient Problem/Medical Problem

  MAUDE report 7699809 ↗
• DeathMay 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED INFORMATION STATING PATIENT WAS UNDERGOING A LATERAL DISCECTOMY/FUSION PROCEDURE. WHILE PERFORMING DISCECTOMY AT THE L4-L5 DISC SPACE, THE ILIAC VEIN WAS LACERATED. THE PATIENT'S HEMODYNAMIC STATUS BECAME UNSTABLE, WAS UNABLE TO BE RESUSCITATED AND SUBSEQUENTLY EXPIRED. THERE IS NO ALLEGATION OF INSTRUMENT MALFUNCTION.

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6574335 ↗