ROI-C MC1443PRecalls & reported problems
LDR Spine Usa, Inc. · ROI-C Lordotic implant H7mm 12 x 14mm · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03662663016544), received between Mar 4, 2020 and May 2, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Failure to Osseointegrate1
Patient problems
- Neck Pain1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- Numbness1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORT THAT A PATIENT EXPERIENCED PAIN EVER SINCE SHE HAD A ROI-C CERVICAL CAGE IMPLANTATION IN 2016. IN 2017, A DOCTOR INFORMED HER THAT THIS DEVICE HAS NOT FUSED. THE PATIENT REPORTED THAT PAIN AND PROBLEMS WITH THE DEVICE ARE GETTING WORSE: SHE IS NOW EXPERIENCING CRACKING AND POPPING SOUNDS IN HER NECK, AND PAIN AND NUMBNESS IN HER HANDS. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: Neck Pain; Numbness; Pain
MAUDE report 21952731 ↗MalfunctionMay 13, 2023Fracture; Fracture
IT WAS REPORTED THAT AN ROI-C CAGE FRACTURED WHILE BEING MALLETED INTO THE DISC SPACE INTRA-OPERATIVELY. THE CAGE AND FRACTURED PIECE WERE RECOVERED AND A NEW CAGE WAS INSTALLED, LEADING TO A DELAY OF 10 MINUTES. THERE WERE NO PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16925968 ↗MalfunctionMar 4, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE THE ANCHORING PLATE WAS DIFFICULT TO INSERT AND THE CAGE BROKE. THE PLATE AND CAGE WERE REMOVED AND REPLACED WITH ALTERNATES TO COMPLETE THE CASE WITH NO REPORTED PATIENT HARM. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9789977 ↗
Other Intervertebral Fusion Device With Integrated Fixation, Cervical devices
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- Divergence® Anterior Cervical Fusion System G6626525Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical75 reports
- Divergence® Anterior Cervical Fusion System G6626526Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical49 reports
- NA 03.617.905Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical29 reports
- NA 03.617.904Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical27 reports
- Divergence® Anterior Cervical Fusion System G6626746Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical21 reports
- NA 03.647.972Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical17 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.