Skip to content

ROI-C MC1352PRecalls & reported problems

LDR Spine Usa, Inc. · ROI-C IMPLANT 12X15.5 H6 · 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 03662663016353), received between Oct 29, 2020 and Oct 29, 2020 — 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 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.

  • MalfunctionOct 29, 2020Fracture; Fracture

    IT WAS REPORTED THAT DURING A PROCEDURE, AN ROI-C FRACTURED DURING PLATE INSTALLATION; THE PATE WOULD NOT ADVANCE WITHOUT SEVERAL VERY HARD HITS WITH A MALLET. THE CAGE AND PLATE WERE REMOVED FROM THE WOUND AND REPLACED WITH AN ALTERNATIVE CAGE AND PLATE TO COMPLETE THE PROCEDURE. IT WAS ALSO REPORTED THAT X-RAYS WERE NOT TAKEN PRIOR TO PLATE INSTALLATION TO ENSURE PROPER CAGE PLACEMENT AND DISTANCE FROM THE RETRACTION PINS. THERE WERE NO REPORTED PATIENT IMPACTS ASSOCIATED WITH THIS EVENT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10759709 ↗

Other Intervertebral Fusion Device With Bone Graft, Cervical devices

All Intervertebral Fusion Device With Bone Graft, Cervical devices →

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