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ROI-C MC1341PRecalls & reported problems

LDR Spine Usa, Inc. · ROI-C IMPLANT 12X14 H5 · 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 03662663016278), received between Jun 25, 2019 and Jun 25, 2019 — classified as 1 malfunction.

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

  • Break1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJun 25, 2019Break; Break

    IT WAS REPORTED THAT A CAGE BROKE WHILE IMPACTING THE FIRST ANCHORING PLATE. THE SURGERY WAS COMPLETED WITH ANOTHER IMPLANT. THERE WAS NO IMPACT TO THE PATIENT REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8731227 ↗

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