ROI-C MC9091RRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03662663043649), received between Mar 25, 2021 and Aug 19, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Fracture

  It was reported that during a two-level ROI-C procedure, the hook of the cage holder fractured. After the blade was inserted into the second level, the hook fractured while the surgeon was withdrawing the holder from the cage. The broken hook tip was ultimately found outside of the surgical site and there was no patient or procedural impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50332891 ↗
• MalfunctionJul 10, 2026Fracture

  Patient problems: Foreign Body In Patient

  MAUDE report 25782426 ↗
• MalfunctionOct 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE HOOK OF THE ROI-C INSERTER BROKE OFF AND REMAINED ATTACHED TO THE CAGE SLOT, RESULTING IN ITS RETENTION INSIDE THE BODY. AS A RESULT, BOTH THE CAGE AND THE BLADE WERE REMOVED. THERE WAS A 30 MINUTE DELAY ASSOCIATED WITH THIS EVENT, BUT NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381133 ↗
• MalfunctionAug 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, AS THE SURGEON DETACHED THE IMPLANT HOLDER FROM THE IMPLANT, THE IMPLANT HOLDER HOOK FRACTURED. ALL PIECES WERE RETRIEVED WITHOUT PATIENT HARM OR SURGICAL DELAYS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075700 ↗
• MalfunctionJul 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF AN ROI-C IMPLANT HOLDER BODY BROKE OFF INTRA-OP. A SECOND INSERTER WAS USED TO COMPLETE THE CASE. THERE WAS NO DELAY OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093480 ↗
• MalfunctionJun 29, 2022Fracture; Fracture

  IT WAS REPORTED THE HOOK ON TWO ROI-C INSERTERS FRACTURED OFF WHILE INSTALLING THE CAGES INTRA-OPERATIVELY. THE FINAL CAGE WAS SUCCESSFULLY INSTALLED USING ONE OF THE BROKEN INSERTERS. THE FRACTURED PIECES WERE RECOVERED AND THERE WERE NO PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14853049 ↗
• MalfunctionJun 29, 2022Fracture; Fracture

  IT WAS REPORTED THE HOOK ON TWO ROI-C INSERTERS FRACTURED OFF WHILE INSTALLING THE CAGES INTRA-OPERATIVELY. THE FINAL CAGE WAS SUCCESSFULLY INSTALLED USING ONE OF THE BROKEN INSERTERS. THE FRACTURED PIECES WERE RECOVERED AND THERE WERE NO PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14853042 ↗
• MalfunctionDec 7, 2021Fracture; Fracture

  IT WAS REPORTED THE HOOKS BROKE OFF THE TIP OF TWO ROI-C INSERTERS DURING A PRODUCT TRAINING. THERE WAS NOT A PATIENT PRESENT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12956791 ↗
• MalfunctionDec 7, 2021Fracture; Fracture

  IT WAS REPORTED THE HOOKS BROKE OFF THE TIP OF TWO ROI-C INSERTERS DURING A PRODUCT TRAINING. THERE WAS NOT A PATIENT PRESENT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12956746 ↗
• MalfunctionOct 4, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE HOOK BROKE OFF THE TIP OF AN IMPLANT INSERTER WHILE INSTALLING THE IMPLANT INTRA-OPERATIVELY. THE HOOK WAS RETRIEVED FROM THE PATIENT AND THERE WERE NO PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568128 ↗
• MalfunctionJun 7, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE HOOK BROKE OFF OF AN INSERTER INTRA-OPERATIVELY WHILE THE SURGEON WAS DETACHING IT FROM THE CAGE. THE SURGEON USED ANOTHER INSTRUMENT TO REMOVE THE HOOK FROM THE WOUND. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11948028 ↗
• MalfunctionJun 7, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE HOOK BROKE OFF OF AN INSERTER INTRA-OPERATIVELY WHILE THE SURGEON WAS DETACHING IT FROM THE CAGE. THE SURGEON USED ANOTHER INSTRUMENT TO REMOVE THE HOOK FROM THE WOUND. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11947955 ↗
• MalfunctionMar 25, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE INSERTER HOOK OF THE INSERTER BROKE OFF DURING SURGERY. THE BROKEN TIP WAS RETRIEVED AND THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11571361 ↗