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ROI-C MC1432PRecalls & reported problems

LDR Spine Usa, Inc. · ROI-C Lordotic Implant 14x17H6 · Class 2

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 03662663016476), received between Jan 25, 2021 and Jan 25, 2021 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Crack1

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.

  • MalfunctionJan 25, 2021Crack; Crack

    IT WAS REPORTED THAT DURING AN INITIAL SURGERY, A ROI-C PLATE BENT AND THE CAGE WAS FOUND TO CRACKED. ANOTHER CAGE AND PLATES WERE SUCCESSFULLY IMPLANTED. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 11222898 ↗

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