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ROI-C CMC1442PRecalls & reported problems

LDR Spine Usa, Inc. · ROI-C LORDOTIC COATED IMPLANT 12x14 H6 · Class 2 · Implant

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 03662663023542), received between Feb 24, 2021 and Feb 24, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (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

  • Mechanical Jam1

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 24, 2021Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT AN ANCHORING PLATE BECAME STUCK DURING INSERTION INTO A CAGE. THE SURGEON REMOVED THE STUCK ANCHORING PLATE AND CAGE. THE SURGERY WAS COMPLETED USING A NEW CAGE AND THE OTHER ORIGINAL ANCHORING PLATE THAT WAS NOT STUCK. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11372171 ↗

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Sources and updates

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