CoRoent 6790114Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517359933), received between Oct 26, 2022 and Oct 26, 2022 — classified as 1 injury.

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.

• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISC FUSION PROCEDURE FROM C6-C7. WHILE THE SURGEON WAS TURNING THE ANGLED DRIVER THE WINDOWS ON THE SIDE OF THE DRIVER ALLOWED THE INNER SHAFT TO CAPTURE A BRANCH OF THE CAROTID ARTERY AS THE INTERNAL SHAFT SPUN. AS A CONSEQUENCE A BRANCH OF THE CAROTID ARTERY WAS TORN. THE SURGEON ALERTED THE VASCULAR SURGEON WHO REPAIRED THE ARTERY. 50ML OF BLOOD LOSS WERE RECORDED AND NO INFUSION WAS REQUIRED AND HEMOSTASIS WAS RESTORED. THE EVENT RESULTED IN A ROUGHLY 30 MINUTE SURGICAL DELAY AND THE SURGERY WAS COMPLETED WITH NO FURTHER ISSUE. THE PATIENT IS RECOVERING WELL POST-OP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15674605 ↗