CoRoent 6050823P2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517722652), received between Apr 6, 2022 and Dec 2, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 DURING SURGERY TO INSERT TWO CAGES INTO L5/S BY TRANSFORAMINAL LUMBAR INTERBODY FUSION, THE FIRST CAGE WAS INSERTED WITHOUT PROBLEMS, AND WHILE INSERTING THE SECOND CAGE, THE SPINAL CAGE BROKE THROUGH THE ALL (ANTERIOR LONGITUDINAL LIGAMENT). THE SURGEON ATTEMPTED TO PULL IT BACK WITH AN INSERTER THAT RESULTED IN THE SPINAL CAGE COMPLETELY PUSHING OUT ANTERIORLY. THE SURGERY WAS TERMINATED WITH ONE CAGE PLACED AND FIXATION WITH SCREWS. THE SPINAL CAGE THAT BROKE THROUGH THE ALL AND CAME OUT ANTERIORLY WILL BE REMOVED LATER. NO REVISION CURRENTLY SCHEDULED.

  Patient problems: Damage to Ligament(s); Foreign Body In Patient

  MAUDE report 15911570 ↗
• InjuryApr 6, 2022Malposition of Device; Malposition of Device

  ON A (B)(6) 2022 A PATIENT UNDERWENT A POSTERIOR LATERAL INTERBODY FUSION PROCEDURE ON THE LUMBAR REGION OF THE SPINE. DURING THE PROCEDURE WHILE INSERTING THE SPACER CAGE IN-BETWEEN L5-SACRUM THE CAGE FELL VENTRALLY. IT WAS REPORTED THAT A CONTRIBUTOR WAS PERFORATION OF THE ANTERIOR LONGITUDINAL LIGAMENT BY GRAFTED BONE FILLED IN THE CAGE. AT THE TIME THE SURGEON DETERMINED RETRIEVAL OF THE CAGE WOULD BE UNSAFE AND LEFT THE MALPLACED IMPLANT IN-SITU. THE SURGERY WAS COMPLETED FINAL TIGHTENING. CT SCAN SHOWED NO CHANGE IN THE CAGE POSITION AND NO ADVERSE EFFECTS WERE DETERMINED, IT WAS DECIDED TO LEAVE THE CAGE IN SITU AND THE PATIENT WILL BE MONITORED.

  Patient problems: Damage to Ligament(s); Laceration(s)

  MAUDE report 14023908 ↗