ROI-C MC1005TRecalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 03662663016971), received between May 2, 2019 and Aug 27, 2026 — classified as 8 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (15 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Failure to Advance; Material Twisted/Bent

  It was reported that when inserting the second anchoring plate of the ROI-C at C4/C5, it could not be advanced at all. When the plate was removed, it was found to be bent. It is suspected that the first plate had not been fully inserted, which may have caused interference with the second plate. The first plate was driven in again until it was fully seated. Another box was opened, and a replacement plate was used to continue the procedure. There were no reported patient impacts.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484099 ↗
• MalfunctionJan 26, 2026Difficult to Insert

  IT WAS REPORTED THAT AN ROI-C ANCHORING PLATE WAS UNABLE TO BE INSERTED INTO THE PATIENT'S VERTEBRAL BODY BECAUSE THE BONE WAS TOO HARD. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183940 ↗
• MalfunctionJan 13, 2026Difficult to Insert

  IT WAS REPORTED THAT INTRA-OPERATIVELY, IT WAS IMPOSSIBLE TO IMPACT THE ROI-C ANCHORING PLATES DUE TO PATIENT HAVING TOO STRONG BONE. OTHER ANCHORS WERE USED TO COMPLETE THE SURGERY AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059920 ↗
• MalfunctionDec 22, 2025Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT AT THE END OF A SURGERY, AFTER IMPACTING THE ROI-C ANCHORS, THE SURGEON NOTICED THAT A SMALL PIECE OF METAL WAS FLOATING AFTER RINSING. IT APPEARS TO BE A PIECE OF THE ANCHORING PLATE THAT BROKE DURING IMPACTION, EVEN THOUGH THE SURGICAL TECHNIQUE WAS FOLLOWED CORRECTLY. THERE WAS NO PATIENT IMPACT AND THE ANCHORING PLATE REMAINS IMPLANTED; THE SURGEON WAS ABLE TO RETRIEVE THE SMALL PIECE OF METAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873229 ↗
• MalfunctionJun 24, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT AFTER CAGE INSERTION, A PILOT HOLE WAS DRILLED TO FULL DEPTH WITH AN AWL, BUT THE ANCHORING PLATE WAS NOT ABLE TO GO IN ALL THE WAY. THE PLATE WAS DISCARDED, THE DEPTH WAS ADJUSTED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PLATE WITHOUT RESULTING IN ANY PATIENT HARM, AND ONLY A 10 MINUTE PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320288 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 TWO OF THREE FOR THIS EVENT.

  Patient problems: Neck Pain; Numbness; Pain

  MAUDE report 21952606 ↗
• 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 ONE OF THREE FOR THIS EVENT.

  Patient problems: Neck Pain; Numbness; Pain

  MAUDE report 21952601 ↗
• InjuryOct 31, 2024Failure to Osseointegrate; Patient-Device Incompatibility; Failure to Osseointegrate; Patient-Device Incompatibility

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED 1-2 YEARS POST-OPERATIVELY TO ADDRESS METALLOSIS AND NON-FUSION OF AN ROI-C PATIENT. THE PATIENT WAS EXPERIENCING PAIN PRIOR TO THE REVISION. USING SPECT-CT, THE SURGEON DETERMINED THAT THE CAGE WAS LOOSE AND THAT THERE WAS A VISIBLE AMOUNT OF METALLOSIS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 20578717 ↗
• MalfunctionMar 22, 2024Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AN ROI-C ANCHORING PLATE FRACTURED DURING IMPLANTATION BECAUSE THE SURGEON ATTEMPTED TO PLACE TWO PLATES IN THE SAME LOCATION. WHEN THE MISTAKE WAS REALIZED, THE PLATE WAS REMOVED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961138 ↗
• InjuryJul 12, 2023Fracture; Fracture

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED TO ADDRESS AN ANCHOR PLATE THE FRACTURED POST-OPERATIVELY. THE PATIENT WAS CONVERTED TO A FUSION AND IS DOING WELL. THE PLATE REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17311904 ↗
• MalfunctionApr 14, 2023Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT AN ROI-C PLATE WAS DIFFICULT TO INSTALL THEN BENT AND A CAGE BROKE INTRA-OPERATIVELY. THEY WERE BOTH REMOVED AND REPLACED 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 16746660 ↗
• MalfunctionMar 31, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE ANCHORING PLATE WOULD NOT ADVANCE THROUGH THE PATIENT'S BONE AT C4 OF A C4/5 ROI-C CONSTRUCT INTRAOPERATIVELY. WHILE REMOVING THE PLATE, THE CAGE CRACKED. BOTH COMPONENTS WERE REMOVED AND REPLACED WITH NEW ONES TO COMPLETE THE PROCEDURE. THE SURGEON SAID THE PATIENT HAD HARD, SCLEROTIC BONE SO HE USED THE AWL AT THAT LEVEL PRIOR TO REINSTALLING THE PLATES. THERE WERE NO PATIENT IMPACTS, BUT THERE WAS A DELAY OF 20 MINUTES TO REMOVE AND THE CAGE AND PLATE. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658376 ↗
• MalfunctionMar 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT AN ROI-C SUPERIOR PLATE AT C5/6 WAS FOUND TO HAVE FRACTURED SIX MONTHS POST-OPERATIVELY VIA X-RAYS. THE PATIENT WAS INACTIVE AND THE CAGE DID NOT SHOW SIGNS OF SINKING (MOVEMENT) POST-OPERATIVELY. THE AWL WAS USED PRIOR TO INSTALLING THE PLATES WHEN THEY WERE INSTALLED IN THE PATIENT. THERE ARE NO HEALTH IMPACTS AND NO PLANS FOR A REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16480984 ↗
• MalfunctionFeb 13, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ROI-C PLATES HAD A HARD TIME PASSING THROUGH THE IMPLANT HOLDER AND CAUSED THE CAGE TO BREAK. THE CAGE WAS REMOVED AND REPLACED WITH A SECOND CAGE, BUT IT ALSO BROKE WHILE TRYING TO ADVANCE THE PLATES. THIS CAGE WAS ALSO REMOVED AND THE HOLDER AND PLATES WERE SWITCHED OUT. THE SECOND SET OF PLATES WERE SUCCESSFULLY INSTALLED INTO THE THIRD CAGE USING THE SECOND HOLDER. AN AWL WAS NOT NEEDED AND THE PATIENT DID NOT HAVE HARD BONE. THERE WERE NO PATIENT IMPACTS.THIS IS REPORT THREE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362563 ↗
• MalfunctionNov 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE ONE-YEAR POST-OPERATIVE X-RAY SHOWED A FRACTURE OF THE C5/6 SUPERIOR ANCHORING PLATE. NO COMPLICATIONS FOR THE PATIENT SO FAR. THE SURGEON WILL MONITOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15831051 ↗
• MalfunctionOct 7, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHILE INSTALLING THE ROI-C PLATES INTRA-OPERATIVELY, THE PATIENT'S BONE WAS VERY HARD AND DENSE, AND THEY HAD TO START OVER SEVERAL TIMES TO PUT IN THE PLATES. THERE WAS A 30-MINUTE DELAY AND NO IMPACT TO THE PATIENT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15568469 ↗
• MalfunctionOct 7, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHILE INSTALLING THE ROI-C PLATES INTRA-OPERATIVELY, THE PATIENT'S BONE WAS VERY HARD AND DENSE, AND THEY HAD TO START OVER SEVERAL TIMES TO PUT IN THE PLATES. THERE WAS A 30-MINUTE DELAY AND NO IMPACT TO THE PATIENT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15568442 ↗
• MalfunctionOct 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT AN ROI-C ANCHORING PLATE WAS DISCOVERED BROKEN POSTOPERATIVELY AFTER THE PATIENT STARTED HAVING PAIN. THE SURGEON HAS NOT YET DECIDED IF A REVISION WILL BE PERFORMED.

  Patient problems: Pain

  MAUDE report 15523601 ↗
• MalfunctionSep 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE CRANIAL PLATE OF AN ROI-C CONSTRUCT WAS FOUND BROKEN AT THE ONE YEAR POST-OPERATIVE FOLLOW-UP. THE PATIENT IS ASYMPTOMATIC AND IS HAPPY WITH THE RESULTS, SO THE SURGEON IS NOT PLANNING A REVISION TO REMOVE OR REPLACE THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15475617 ↗
• MalfunctionSep 1, 2022Fracture; Fracture

  IT WAS REPORTED AN ROI-C CAGE AND PLATE WERE BROKEN DURING INSTALLATION WITHIN SURGERY. THE REMOVAL OF THESE IMPLANTS CAUSED A DELAY OF 30 MINUTES BUT THE PATIENT IS IN GOOD CONDITION AFTER SURGERY AND HAS BEEN DISCHARGED FROM THE HOSPITAL. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15342140 ↗
• MalfunctionAug 29, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THE THE HOOK BROKE OFF AN ROI-C IMPLANT HOLDER AND A PLATE BECAME STUCK IN THE HOLDER INTRA-OPERATIVELY. THERE WERE NO PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15311157 ↗
• MalfunctionAug 17, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A WAREHOUSE FOUND AN ROI-C CAGE THAT IS FRACTURED AND A PLATE THAT HAS A BENT ARM DURING INSPECTION AFTER THEY WERE RETURNED FROM A HOSPITAL. FOLLOW-UP WITH THE DISTRIBUTOR DETERMINED THE ANCHORS WERE TOO SMALL FOR THE PATIENT'S VERTEBRAL BODY. THE CAGE AND ANCHORS WERE REMOVED AND REPLACED WITH ANOTHER LARGER SIZE. SURGERY WAS DELAYED APPROXIMATELY 30 MINUTES. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15240069 ↗
• MalfunctionAug 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT AN ROI-C CAGE AND PLATE FRACTURED INTRA-OPERATIVELY. THE CAGE FRACTURED ON THE ANTERIOR SURFACE WHERE THE PLATES SNAP INTO PLACE; THE FRACTURE PIECE WAS RECOVERED. THE SECOND PLATE LOOKS TO HAVE FRACTURED. AN AWL WAS USED TO PRIOR TO INSTALLING THE FIRST PLATE AS THE PATIENT HAD HARD BONE, BUT IT WAS NOT USED PRIOR TO INTRODUCTION OF THE SECOND PLATE. THE FULL CONSTRUCT REMAINS IMPLANTED BECAUSE IT WAS WELL-POSITIONED. THERE WAS A SHORT DELAY WITHOUT PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218557 ↗
• MalfunctionJun 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A ROI-C PLATE WOULD NOT FIT IN THE CAGE INTRA-OPERATIVELY. THERE WERE NO REPORTED PATIENT IMPACTS. DEVICE EVALUATION BY THE MANUFACTURER FOUND THE PLATE WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754253 ↗
• MalfunctionMay 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT A BROKEN ROI-C ANCHORING PLATE WAS FOUND IN AN X-RAY TAKEN APPROXIMATELY 6 MONTHS POSTOPERATIVELY. ALSO, THE SURGEON BELIEVES THE CAGE MAY HAVE SUBSIDED. THE CAGE WAS PLACED AT LEVEL C5/6 AND THE PLATE BROKE AT C6. AT THIS TIME, THERE ARE NO REPORTED PLANS FOR REVISION SURGERY, BUT THE PATIENT IS FEELING SOME NUMBNESS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Numbness

  MAUDE report 14337324 ↗