Skip to content

ROI-C MC1453PRecalls & reported problems

LDR Spine Usa, Inc. · ROI-C LORDOTIC MPLANT H7MM 12X15.5MM · Class 2

All models of ROI-C (39)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03662663016605), received between Aug 18, 2023 and Aug 18, 2023 — 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

Device problems

  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 18, 2023Fracture; Fracture

    IT WAS REPORTED THAT A PIECE OF AN ROI-C CAGE BROKE WHILE IT WAS BEING INSTALLED INTO THE DISC SPACE. THE CAGE WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT IMPACTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17572014 ↗

Other Intervertebral Fusion Device With Integrated Fixation, Cervical devices

All Intervertebral Fusion Device With Integrated Fixation, Cervical devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page