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ROI-A IR2532PRecalls & reported problems

LDR Spine Usa, Inc. · ROI-A MEDIAN IMPLANT PXL 27X30 H12 10° · 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 03662663011358), received between May 22, 2023 and May 22, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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

  • Crack1

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 22, 2023Crack; Crack

    IT WAS REPORTED THAT AN ROI-A CAGE BROKE, ALLOWING IT TO DETACH FROM IMPLANT HOLDER WHILE THE FIRST PLATE WAS BEING INSTALLED INTRAOPERATIVELY. THE CAGE AND PLATE WERE REMOVED AND REPLACED WITH ANOTHER CAGE AND BOTH PLATES WERE SUCCESSFULLY INSTALLED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF 20 MINUTES WITHOUT PATIENT IMPACTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16973320 ↗

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Sources and updates

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