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ROI-A IR5341PRecalls & reported problems

LDR Spine Usa, Inc. · ROI-A median implant H14mm 30x39mm 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 03662663014243), received between Jul 25, 2019 and Jul 25, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Problem” (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

  • Positioning Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 25, 2019Positioning Problem; Positioning Problem

    THIS MDR REPORT WAS SUBMITTED IN ERROR. THERE IS NO INFORMATION AVAILABLE THAT SUGGESTS THAT THERE WAS A MALFUNCTION OF THE DEVICE. ADDITIONALLY, THE DEVICE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8825404 ↗

Other Intervertebral Fusion Device With Integrated Fixation, Lumbar devices

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Sources and updates

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