ROI-C MC1006TRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03662663016988), received between Mar 4, 2020 and Feb 11, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Malposition of Device

  IT WAS REPORTED THAT TWO ROI-C CAGES FRACTURED INTRA-OPERATIVELY AT C6/7 WHILE IMPLANTING THE SUPERIOR PLATES BEFORE LOCKING. THE PLATES WERE MISALIGNED DESPITE USING THE AWL SUCCESSFULLY. THE LEVEL ABOVE HAD A PREVIOUS PLATE/SCREW CONSTRUCT AND THE PROCEDURE WAS AN EXTENSION OF THE PREVIOUSLY SUCCESSFUL FUSION. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A COMPETITIVE PRODUCT. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 60 MINUTE DELAY. UPON INVESTIGATION IT WAS DISCOVERED THAT ONE OF THE PLATES WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315176 ↗
• MalfunctionDec 11, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A SURGEON WAS EXPERIENCING ISSUES WITH INSERTING AN ROI-C ANCHORING PLATE INTRA-OPERATIVELY. THE PATIENT WAS REPORTED TO HAVE HARD BONE, WHICH PREVENTED THE LONG PLATE FROM BEING FULLY INSTALLED. THE SURGEON SWITCHED TO A SHORT PLATE TO COMPLETE THE PROCEDURE WITHOUT ISSUES. THERE WERE NO REPORTED PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20907038 ↗
• MalfunctionNov 28, 2023Difficult to Insert; Difficult to Insert

  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 TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222549 ↗
• MalfunctionMar 28, 2022Difficult to Insert; Difficult to Insert

  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 ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929287 ↗
• MalfunctionJan 26, 2022Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT A CAGE BROKE INTRA-OPERATIVELY WHILE THE MATING PLATE WAS BEING REMOVED BECAUSE THE PLATE WOULD NOT SEAT INTO THE CAGE. THE CAGE AND PLATE WERE REMOVED AND REPLACED WITH A COMPETITIVE CONSTRUCT TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. DEVICE EVALUATION BY THE MANUFACTURER FOUND THE PLATE HAD ALSO FRACTURED. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359704 ↗
• MalfunctionJul 21, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHILE INSERTING A PLATE THROUGH THE CAGE, THE PLATE BECAME STUCK AND COULD NOT BE ADVANCED OR REMOVED. THE CAGE WAS BROKEN TO REMOVE THE PLATE. THE CAGE WAS ALSO REMOVED AND BOTH PIECES WERE REPLACED WITH COMPETITIVE PRODUCT TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203140 ↗
• MalfunctionDec 1, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED AN ROI-C PLATE AT C5 BENT UPON IMPACTION CAUSING THE CAGE TO CRACK. BOTH THE CAGE AND PLATES WERE EXPLANTED. THE SAME SIZE CAGE AND PLATE WERE USED TO REPLACE THE EXPLANTED DEVICES. AFTER USING THE AWL, THE TOP PLATE AT C5 BENT AGAIN. THE SURGEON REMOVED THE BENT PLATE AND LEFT THE CAGE WITH ONE PLATE OF FIXATION. THERE WAS NO KNOWN PATIENT IMPACT. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10927513 ↗
• MalfunctionDec 1, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED AN ROI-C PLATE AT C5 BENT UPON IMPACTION CAUSING THE CAGE TO CRACK. BOTH THE CAGE AND PLATES WERE EXPLANTED. THE SAME SIZE CAGE AND PLATE WERE USED TO REPLACE THE EXPLANTED DEVICES. AFTER USING THE AWL, THE TOP PLATE AT C5 BENT AGAIN. THE SURGEON REMOVED THE BENT PLATE AND LEFT THE CAGE WITH ONE PLATE OF FIXATION. THERE WAS NO KNOWN PATIENT IMPACT. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10927418 ↗
• MalfunctionOct 13, 2020Fracture; Difficult to Insert; Fracture; Difficult to Insert

  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 SIX OF SIX FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10674831 ↗
• MalfunctionOct 13, 2020Fracture; Difficult to Insert; Fracture; Difficult to Insert

  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 FOUR OF SIX FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10674802 ↗
• MalfunctionMar 4, 2020Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  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 TWO OF TWO FOR THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9790139 ↗