ROI-C MC1342PRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03662663016285), received between May 2, 2019 and Sep 1, 2022 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15342181 ↗
• MalfunctionMay 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT UPON PLACING THE IMPLANT AND PLATE INTO THE DISC SPACE, THEY BROKE. THE SURGEON REMOVED THEM AND USED NEW DEVICES TO COMPLETE THE SURGERY. NO DEBRIS WAS CREATED. THERE WAS NO REPORTED DELAY OF SURGERY OR HARM TO THE PATIENT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871439 ↗
• MalfunctionMar 16, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY THE PLATES COULD NOT BE COMPLETELY INSERTED INTO THE CAGE. THE SURGEON HAD DIFFICULTY REMOVING THE PLATES AND THE CAGE AND ALL THREE ITEMS WERE DAMAGED DURING REMOVAL. A NEW CAGE AND PLATES WERE USED TO COMPLETE THE SURGERY WITHOUT IMPACT ON THE PATIENT. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496827 ↗
• MalfunctionJan 13, 2021Fracture; Fracture

  IT WAS REPORTED THAT AN ROI-C CAGE BROKE WHILE THE SURGEON WAS IMPACTING THE PLATE TO COMPLETE THE CONSTRUCT ASSEMBLY IN SURGERY. THE CAGE AND PLATE WERE REMOVED AND REPLACED WITH ANOTHER CAGE AND PLATE TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT IMPACTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11158256 ↗
• MalfunctionNov 18, 2020Fracture; Fracture

  IT WAS REPORTED THAT AN ROI-C CAGE FRACTURED DURING SURGERY WHILE THE MATING PLATE WAS BEING INSTALLED. THE CAGE WAS REMOVED, AND REPLACED WITH AN ALTERNATIVE CAGE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT IMPACTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10864589 ↗
• MalfunctionOct 23, 2020Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT AN ROI-C PLATE BECAME JAMMED INSIDE THE CAGE DURING ATTEMPTED ASSEMBLY INTRA-OPERATIVELY. IN ORDER TO REMOVE THE PLATE, THE SURGEON BROKE THE CAGE. BOTH PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND REPLACED WITHOUT REPORTED PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10727392 ↗
• MalfunctionNov 27, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SECOND ANCHORING PLATE WAS ALMOST FULLY INSERTED WHEN IT BECAME JAMMED AND WOULD NOT ADVANCE FURTHER. THE CAGE CRACKED AND THE PLATES AND CAGE WERE REMOVED. AN ALTERNATE CAGE AND PLATES OF THE SAME SIZE WERE INSERTED TO COMPLETE THE CASE. THERE WERE NO REPORTED SURGICAL DELAYS OR PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9387284 ↗
• MalfunctionJul 29, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, A CAGE BROKE UPON IMPLANTING. THE CAGE WAS REPLACED WITH A NEW ONE OF THE SAME SIZE AND SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL IMPACT OR PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8835390 ↗
• MalfunctionJul 29, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, A CAGE FRACTURED WHILE BEING FILLED WITH BONE SUBSTITUTE. THE CAGE WAS DISCARDED AND A NEW CAGE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT OR SURGICAL IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8835305 ↗
• InjuryMay 2, 2019Break; Break

  ROI-C: BROKEN CAGE DURING IMPLANTATION. IT WAS REPORTED THAT DURING A ROI-C SURGERY THE CAGE BROKE WHEN IT WAS IMPLANTED. THE SURGERY WAS COMPLETED WITH ANOTHER PRODUCT. THE PATIENT IS IN GOOD HEALTH. THE PROCEDURE WAS DELAYED FOR NEARLY 30 MINUTES DUE TO THE NEED TO REMOVE THE DAMAGED CAGE WHEN THE EVENT OCCURRED. THE PATIENT HAD NORMAL BONE MASS. THE CONNECTION BETWEEN CAGE AND CAGE HOLDER WAS CORRET. THE SAGITTAL ANGLE WAS RESPECTING HEAD OR FOOT DIRECTION. THE IMPACT SEQUENCE OF ANCHOR PLATE RESPECTS THE SURGICAL TECHNIQUE (FIRST USING IMPACTOR 1, THEN USING IMPACTOR 2) THE FIRST ANCHOR PLATE WAS FULLY IN PLACE BUT THE TWO ANCHORS WERE IMPLANTED IN THE SAME SLOT . NO X-RAYS ARE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8572609 ↗