ROI-C MC1434PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03662663016490), received between Oct 13, 2020 and Nov 28, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE ROI-C IMPLANT WAS PLACED IN THE PATIENT AND THAT UPON MALLETING THE FIRST LONG PLATE, IT BECAME QUITE DIFFICULT TO ADVANCE THE LAST 2MM. THE SURGEON HAD TO MALLET QUITE HARD TO FINISH PLACING THE LONG PLATE IN THE CORRECT POSITION. THE SECOND LONG PLATE WAS ALSO MORE DIFFICULT THAN USUAL. THE SURGEON DID NOT USE THE AWLS AS HE DID NOT BELIEVE THE BONE WAS HARD ENOUGH TO MERIT THEM. UPON REMOVAL OF THE INSERTER HANDLE, IT WAS NOTED THAT A PIECE OF THE PEEK IMPLANT HAD CHIPPED OFF. THE SURGEON TUGGED ON THE PLATES TO ENSURE THEY WERE SECURE WITHOUT THE CHIPPED PIECE AND THE IMPLANT WAS LEFT IN PLACE. THERE WAS A 10-MINUTE DELAY WITHOUT IMPACT ON THE PATIENT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222548 ↗
• MalfunctionMar 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT A ROI-C CAGE AND PLATE BROKE WHEN THE SURGEON PUT IN THE LONG ANCHORING PLATE; THE AWL WAS NOT USED TO PREPARE THE BONE AND THE PATIENT HAD HARD BONE. THE CAGE AND PLATE WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929295 ↗
• MalfunctionFeb 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT A ROI-C CAGE CRACKED INTRA-OPERATIVELY. IT WAS FOUND FRACTURED AFTER REMOVING THE INSERTER. THE IMPLANT WAS REMOVED AND ANOTHER ONE WAS USED TO COMPLETE THE CASE WITHOUT IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13606882 ↗
• MalfunctionOct 13, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE AT THE C7/T1 LEVEL THE ANCHORING PLATE WAS DIFFICULT TO INSERT THE SECOND PLATE. THE CAGE WAS FOUND TO BE FRACTURED, THE PLATE AND CAGE WERE REMOVED AND REPLACED WITH ALTERNATES OF THE SAME SIZE. AT THE C6/C7 LEVEL THE FIRST ANCHORING PLATE WAS HINDERED BY THE SUPERIOR ENDPLATE OF C7 AND WHEN THE SURGEON IMPACTED TO INSERT THE PLATE AND CAGE BROKE. AT THE C6 LEVEL THE ANCHORING PLATE WAS DIFFICULT TO INSERT AND BOTH THE CAGE AND ANCHORING PLATE BROKE. THEY WERE REMOVED AND REPLACED WITH ALTERNATES. THE SURGEON OPTED TO NOT USE ANCHORING PLATES AT C6 AND C7 LEVELS. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT FIVE OF SIX FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10674845 ↗
• MalfunctionOct 13, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE AT THE C7/T1 LEVEL THE ANCHORING PLATE WAS DIFFICULT TO INSERT THE SECOND PLATE. THE CAGE WAS FOUND TO BE FRACTURED, THE PLATE AND CAGE WERE REMOVED AND REPLACED WITH ALTERNATES OF THE SAME SIZE. AT THE C6/C7 LEVEL THE FIRST ANCHORING PLATE WAS HINDERED BY THE SUPERIOR ENDPLATE OF C7 AND WHEN THE SURGEON IMPACTED TO INSERT THE PLATE AND CAGE BROKE. AT THE C6 LEVEL THE ANCHORING PLATE WAS DIFFICULT TO INSERT AND BOTH THE CAGE AND ANCHORING PLATE BROKE. THEY WERE REMOVED AND REPLACED WITH ALTERNATES. THE SURGEON OPTED TO NOT USE ANCHORING PLATES AT C6 AND C7 LEVELS. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT THREE OF SIX FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10674786 ↗