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ROI-C MC1454PRecalls & reported problems

LDR Spine Usa, Inc. · ROI-C LORDOTIC IMPLANT H8MM 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 03662663016612), received between Feb 3, 2023 and Feb 3, 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.

  • MalfunctionFeb 3, 2023Fracture; Fracture

    IT WAS REPORTED THAT AN ROI-C PLATE WOULD NOT ADVANCE INTO THE PATIENT'S SCLEROTIC BONE, THEN CAUSED THE CAGE TO CRACK WHEN THE PLATE WAS BEING REMOVED. BOTH A NEW CAGE AND PLATE WERE INSTALLED USING THE AWL TO COMPLETE THE SURGERY WITHOUT PATIENT IMPACTS. THERE WAS A FIVE MINUTE TO DELAY TO THE PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16296454 ↗

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Sources and updates

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