ROI-C MC9001RRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03662663043168), received between Dec 3, 2020 and May 28, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryMay 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ROI-C PROCEDURE, WHILE TRYING TO DISENGAGE THE IMPLANT FROM THE IMPLANT HOLDER, THE HOOK ON THE IMPLANT HOLDER BROKE OFF AND REMAINED IN THE CAGE. THEY TRIED TO REMOVE IT, BUT THERE WASN'T ENOUGH SPACE OR GRIP TO GRAB IT. SO THEY DECIDED TO LEAVE IT IN PLACE AND CLOSE THE PATIENT. THE HOOK TIP REMAINS STUCK IN THE CERVICAL CAGE BETWEEN VERTEBRAE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22098466 ↗
• MalfunctionDec 11, 2024Fracture; Fracture

  A HOSPITAL REPORTED THAT THE SMALL HOOK ON A ROI-C IMPLANT HOLDER TWISTED AND EVENTUALLY BROKE DURING SURGERY. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903880 ↗
• MalfunctionNov 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE HOOK AT THE TIP OF A ROI-C IMPLANT HOLDER FRACTURED INTRA-OPERATIVELY WHEN THE DOCTOR IMPACTED THE CAGE AND WHEN HE TRIED TO REMOVE THE PIECE THAT LOCKS THE CAGE. IT IS NOT BELIEVED THAT THE PIECE WAS RETAINED IN THE PATIENT SINCE IT DID NOT SHOW UP IN ANY X-RAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610154 ↗
• MalfunctionJun 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE HOOK TIP OF A ROI-C IMPLANT HOLDER FRACTURED WHEN REMOVING FROM THE CAGE INTRA-OPERATIVELY. THE TIP WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469268 ↗
• MalfunctionMar 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT A ROI-C IMPLANT HOLDER BROKE DURING A PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16646366 ↗
• MalfunctionMar 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT AN ROI-C IMPLANT HOLDER BROKE INTRA-OPERATIVELY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645821 ↗
• MalfunctionMar 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE HOOK AT THE TIP OF AN ROI-C IMPLANT HOLDER WAS FRACTURED OFF INTRA-OPERATIVELY WHEN THE SURGEON WAS DETACHING IT FROM THE IMPLANT. THERE WERE NO PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640355 ↗
• MalfunctionAug 29, 2022Fracture; Physical Resistance/Sticking; Fracture; 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 TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15311160 ↗
• MalfunctionDec 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY AFTER INSERTING THE IMPLANT, THE SURGEON WENT TO REMOVE THE HOLDER AND THE HOOK BROKE OFF. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060724 ↗
• MalfunctionDec 17, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE HOOK ON THE TIP OF AN IMPLANT INSERTER BROKE OFF INTRA-OPERATIVELY. THE HOOK WAS RECOVERED WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026223 ↗
• MalfunctionDec 3, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, THE HOOK ON THE IMPLANT HOLDER FRACTURED. AN ALTERNATIVE IMPLANT HOLDER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO IMPACTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10937357 ↗