CoRoent 6791716Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517362438), received between Jun 22, 2016 and Jun 22, 2016 — classified as 1 malfunction.

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

• MalfunctionJun 22, 2016Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2015, A (B)(6) YEAR-OLD FEMALE PATIENT RECEIVED AN ACDF AT THE C6-C7 SPINE LEVEL. CONCURRENTLY, A CERVICAL DISC REPLACEMENT DEVICE WAS IMPLANTED AT THE SUPERIOR ADJACENT LEVEL (C5-C6). ON (B)(6) 2016, THE PATIENT UNDERWENT A REVISION SURGERY THAT INCLUDED REMOVAL OF BOTH THE INTERBODY SPACER AND THE DISC REPLACEMENT DEVICE. IT WAS REPORTED THAT THE INTERBODY SPACER AND ONE OF THE SCREWS HAD FRACTURED. THERE IS NO EVIDENCE THAT THE DISC REPLACEMENT DEVICE EXHIBITED ANY FAULT; THE REASON FOR ITS REMOVAL IS UNKNOWN. IT WAS REPORTED THE PATIENT SUSTAINED INJURIES AS A RESULT OF THE SCREW FRACTURE; HOWEVER, THERE IS NO INFORMATION AVAILABLE TO EVALUATE THE NATURE OF THE REPORTED INJURY.

  Patient problems: No Information

  MAUDE report 5743603 ↗