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ROI-C CMC1332PRecalls & reported problems

LDR Spine Usa, Inc. · ROI-C COATED IMPLANT 14x17 H6 · Class 2 · Implant

All models of ROI-C (39)

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 03662663023221), received between May 24, 2019 and May 24, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1

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.

  • MalfunctionMay 24, 2019Break; Break

    IT WAS REPORTED THAT DURING SURGERY, THE CAGE FRACTURED DURING IMPLANTATION UPON IMPACTION. THE IMPLANT WAS REMOVED AND ANOTHER CAGE OF THE SAME SIZE WAS USED IN ITS PLACE. THERE WAS NO PATIENT HARM OR IMPACT ON THE SURGERY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8640047 ↗

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Sources and updates

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