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ROI-C MC1351PRecalls & reported problems

LDR Spine Usa, Inc. · ROI-C IMPLANT 12X15.5 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 03662663016346), received between Nov 7, 2021 and Nov 7, 2021 — classified as 1 malfunction.

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

  • Fracture1

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.

  • MalfunctionNov 7, 2021Fracture; Fracture

    IT WAS REPORTED THAT THE SECOND ROI-C PLATE WAS DIFFICULT TO INSTALL INTRAOPERATIVELY BECAUSE IT KEPT HITTING THE FIRST PLATE, WHICH CAUSED THE CAGE THE BREAK. THE CAGE AND PLATES WERE REMOVED AND REPLACED WITH COMPETITIVE PRODUCTS TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY WITHOUT REPORTED PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12760814 ↗

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All Spinal Vertebral Body Replacement Device devices →

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