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ROI-C MC1311PRecalls & reported problems

LDR Spine Usa, Inc. · ROI-C IMPLANT 14X14 H5 · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662663016063), received between Dec 22, 2021 and Oct 7, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 7, 2022Fracture; Fracture

    IT WAS REPORTED THAT AN ROI-C CAGE BROKE DURING THE INTRODUCTION OF THE ANCHORING PLATE. THE PLATE WOULD NOT DEPLOY ONCE THE CAGE FRACTURED. THE CAGE AND PLATE WERE REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED PATIENT IMPACTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15565067 ↗
  • MalfunctionDec 22, 2021Fracture; Fracture

    IT WAS REPORTED THAT DURING THE CAGE IMPLANTATION INTRA-OPERATIVELY, A PIECE OF CAGE BROKE OFF; THE PIECE AND CAGE WERE REMOVED AND REPLACED WITH ANOTHER CAGE TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13061930 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.