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ROI-A IR5243PRecalls & reported problems

LDR Spine Usa, Inc. · ROI-A MEDIAN IMPLANT PxL 27X36 H14 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 03662663013802), received between May 20, 2021 and May 20, 2021 — 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.

  • MalfunctionMay 20, 2021Fracture; Fracture

    IT WAS REPORTED THAT A PLATE WOULD NOT ADVANCE INTO THE PATIENT'S BONE. THE SURGEON REMOVED THE PLATE AND ATTEMPTED TO USE AN AWL TO CREATE A PATHWAY FOR THE PLATE, BUT THE CAGE CRACKED. THE CAGE WAS REMOVED AND A NEW CAGE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT OR DELAY OF SURGERY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11855802 ↗

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Sources and updates

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