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ROI-A IR5245PRecalls & reported problems

LDR Spine Usa, Inc. · ROI-A MEDIAN IMPLANT PxL 27X36 H16 14° · Class 2

All models of ROI-A (20)

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 03662663013826), received between Jun 22, 2021 and Jun 22, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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

  • Difficult to Advance1

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.

  • MalfunctionJun 22, 2021Difficult to Advance; Difficult to Advance

    IT WAS REPORTED THAT THE PLATE WOULD NOT ADVANCE DUE TO THE PATIENT'S HARD BONE AND THE CAGE CRACKED. THE SURGEON REMOVED THE PLATE AND CAGE AND ATTEMPTED TO USE THE AWL TO CREATE A PATHWAY FOR THE PLATE. A SECOND CAGE AND PLATE WERE USED TO COMPLETE THE CASE. THERE WERE NO PATIENT IMPACTS OR SURGICAL DELAYS REPORTED. DEVICE EVALUATION BY THE MANUFACTURER FOUND THE PLATE HAD JAMMED INSIDE THE CAGE. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12044370 ↗

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Sources and updates

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