ROI-C MC1321PRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03662663016131), received between Oct 30, 2020 and Dec 21, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT BOTH ROI-C PLATES WERE IMPACTED INTO THE SAME SIDE OF THE CAGE (BOTTOM SIDE OF HOLDER/SUPERIOR SIDE OF CAGE), CAUSING THE CAGE TO BREAK. THE CAGE AND BOTH PLATES WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023729 ↗
• MalfunctionOct 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN ROI-C PLATE JAMMED IN THE CAGE'S SLOT. THE SURGEON REMOVED BOTH PIECES AND TRIED AGAIN OUTSIDE THE PATIENT AND WAS ABLE TO GET THEM TO FIT TOGETHER WITH FORCE. NEITHER ITEM WAS RE-USED AND THE SURGERY CONTINUED WITH A DELAY OF 20 MINUTES, BUT WITHOUT IMPACT TO THE PATIENT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15654937 ↗
• InjuryMar 4, 2021Migration; Migration

  IT WAS REPORTED THAT THE TOP ANCHORING PLATE OF A ROI-C CONSTRUCT BROKE OUT FROM THE BONE AT THE C4/C5 LEVEL THREE DAYS POST OP, ALLOWING THE CAGE TO MIGRATE. THE PATIENT COMPLAINED ABOUT A PALSY ON THE LEFT SIDE AT C5. THE SURGEON PERFORMED A REVISION SURGERY TO REMOVE THE CAGE AND ANCHORING PLATES AND REPLACED THEM BY DOING A CORPECTOMY. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Failure of Implant; Paralysis; Vertebral Fracture

  MAUDE report 11413422 ↗
• InjuryOct 30, 2020Failure to Osseointegrate; Unintended Movement; Failure to Osseointegrate; Unintended Movement

  IT WAS REPORTED THAT A PSEUDOARTHROSIS AND MICROMOVEMENT OF AN ROI-C CONSTRUCT WERE DETECTED AT A THREE-YEAR FOLLOW UP REVIEW. AT THE TIME OF CONSTRUCT PLACEMENT, A DISK REPLACEMENT DEVICE WAS ALSO USED, APPARENTLY AT AN ADJACENT LEVEL. THERE ARE NO CURRENT PLANS FOR A REVISION OF THE ROI_C CONSTRUCT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10760438 ↗