CoRoent 6790225Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887517361608), received between Jun 13, 2018 and Jul 15, 2022 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2022Fracture; Fracture

  DURING A SPINAL FUSION PROCEDURE, THE SURGEON UTILIZED AN AWL WHICH RESULTED IN THE ALREADY PLACED INTERBODY FRACTURING AT THE LATERAL, SCREW SIDE OF THE IMPLANT. ALL PIECES OF THE FRACTURED INTERBODY WERE REMOVED FROM THE PATIENT A NEW INTERBODY OF THE SAME SIZE WAS SUCCESSFULLY PLACED. THERE WAS NO PATIENT OR USER HARM REPORTED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033199 ↗
• MalfunctionJun 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE. DURING PROCEDURE AN INCIDENTAL DUROTOMY AT C4-5 LEVELS OCCURRED. DURAGEN WAS APPLIED PRIOR TO PLACEMENT OF INTERBODY CAGE.

  Patient problems: Injury

  MAUDE report 7603925 ↗
• InjuryJun 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE. APPROXIMATELY SIX HOURS POST-OPERATIVELY PATIENT WAS ADMITTED TO THE HOSPITAL WITH SWELLING IN THE NECK. PATIENT WAS TAKEN BACK FOR AN EMERGENT PROCEDURE WHERE A HEMATOMA WAS FOUND IN THE PREVERTEBRAL SPACE. FURTHER EXPLORATION FOUND ARTERIAL BLEEDING. AS PER REPORTER BLEEDING WAS CAUTERIZED PRIMARILY AND BLEEDING STOPPED.

  Patient problems: Hematoma; Patient Problem/Medical Problem

  MAUDE report 7601013 ↗
• InjuryJun 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013 PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE AT C4-C6 LEVELS. ONE WEEK POSTOPERATIVELY, THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO DIFFICULTY SWALLOWING AND SWELLING IN THE NECK. PATIENT WAS TAKEN TO THE OPERATING ROOM FOR EVACUATION OF A HEMATOMA.

  Patient problems: Hematoma; Patient Problem/Medical Problem

  MAUDE report 7599554 ↗
• MalfunctionJun 13, 2018Break; Break

  ON (B)(6) 2016 PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE. REPORTEDLY, SIX MONTHS POST-OPERATIVELY, INCIDENTAL FINDING OF A FRACTURED SCREW AT THE C6 VERTEBRAL BODY. PATIENT IS ASYMPTOMATIC AND NO REVISION PROCEDURE WILL BE PERFORMED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 7599518 ↗
• InjuryJun 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE. SIX DAYS POST-OPERATIVE, THE PATIENT PRESENTED WITH DIFFICULTY SWALLOWING. ON EXAM SWELLING WAS NOTED AT THE INCISION SITE. PATIENT WAS ADMITTED AND TAKEN TO THE OR FOR EVACUATION OF HEMATOMA. THERE WERE NO COMPLICATIONS ASSOCIATED WITH THE PROCEDURE, PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED AFTER ONE DAY.

  Patient problems: Hematoma; Patient Problem/Medical Problem

  MAUDE report 7599453 ↗