ROI-A IR2008TRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03662663010986), received between Jul 3, 2019 and Jun 4, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Fracture

  IT WAS REPORTED THAT A ROI-A ANCHORING PLATE FRACTURED AT S1 INTRA-OPERATIVELY AND REMAINS IMPLANTED. THE PATIENT IS IN STABLE CONDITION AND UNDER CLINICAL FOLLOW-UP WITHOUT EVIDENCE OF SPACER MIGRATION. NO INTERVENTION IS CURRENTLY PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25400354 ↗
• MalfunctionMay 28, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT INTRA-OPERATIVELY, AN ROI-A PLATE WAS DIFFICULT TO INSERT, AND THIS RESULTED IN THE ROI-A CAGE FRACTURING IN THE DISC SPACE. THE IMPLANTS WERE REMOVED AND ANOTHER CAGE WAS INSTALLED WITHOUT FURTHER COMPLICATIONS. THERE WAS NO PATIENT HARM, BUT THIS DID RESULT IN A PROCEDURAL DELAY OF UNSPECIFIED LENGTH. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097904 ↗
• MalfunctionMay 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT A ROI-A ANCHORING PLATE M FRACTURED POST-OPERATIVELY. THE BREAKAGE WAS DISCOVERED VIA X-RAY DURING A FOLLOW-UP VISIT. THE PATIENT WAS PAIN FREE AND HAD NO COMPLAINTS; THERE WAS NO REPORT OF A FALL OR OTHER ISSUES TO CAUSE THE FRACTURE. IT IS CURRENTLY UNKNOWN IF A REVISION SURGERY IS PLANNED OR NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21954509 ↗
• MalfunctionMay 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT A ROI-A ANCHORING PLATE M FRACTURED POST-OPERATIVELY. THIS WAS DISCOVERED DURING A FOLLOW-UP VISIT VIA X-RAY. THE PATIENT WAS PAIN FREE AND HAD NO COMPLAINTS; THERE WAS NO REPORT OF A FALL OR OTHER ISSUES TO CAUSE THE FRACTURE. IT IS CURRENTLY UNKNOWN WHETHER OR NOT A REVISION WILL BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953759 ↗
• MalfunctionApr 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT A ROI-A CAGE AND A ROI-A ANCHOR PLATE FRACTURED INTRA-OPERATIVELY. THERE WAS NO REPORTED PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY TO THE PROCEDURE. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19186251 ↗
• MalfunctionDec 11, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SECOND ANCHORING PLATE OF AN ROI-A CONSTRUCT COULD NOT BE INSTALLED BECAUSE THE PATIENT HAD HARD BONE AND AN AWL WAS NOT AVAILABLE TO CREATE THE PILOT HOLE FOR THE PLATE. THERE WERE NO PATIENT IMPACTS REPORTED, BUT THE SURGEON WAS NOT SATISFIED WITH THE CONSTRUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301728 ↗
• MalfunctionNov 10, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AN ROI-A CAGE BROKE WHILE THE ANCHORING PLATE WAS BEING IMPACTED THROUGH IT INTRA-OPERATIVELY. THE ANCHORING PLATE WAS ALSO DAMAGED AND COULD NOT BE USED. THE SURGEON DID USE THE AWL TO PREPARE THE PATIENT'S BONE PRIOR TO INSTALLING THE ANCHORING PLATE. THE CAGE AND PLATE WERE REMOVED AND REPLACED WITH ANOTHER CAGE OF A DIFFERENT SIZE AND ANOTHER PLATE TO COMPLETE THE SURGERY. 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 18111797 ↗
• MalfunctionMar 21, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT WHILE THE SURGEON WAS INSTALLING THE FIRST PLATE INTRA-OPERATIVELY, THE PLATE WOULD NOT FULLY ADVANCE. SO THE SURGEON TRIED TO REMOVE IT UTILIZING THE REMOVAL HOOK, BUT THE TIP OF THE REMOVAL HOOK BROKE OFF. THE SURGEON WAS UNABLE TO REMOVE THE PLATE, BUT WAS ABLE TO FURTHER IMPACT IT INTO PLACE SO THAT LOCKED INTO THE CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582657 ↗
• MalfunctionMay 21, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT AN ANCHORING PLATE WOULD NOT ADVANCE DUE TO THE PATIENT'S HARD BONE DURING SURGERY. HOWEVER, DEVICE EVALUATION BY ZIMMER BIOMET PERSONNEL FOUND THAT THE ANCHORING PLATE WAS JAMMED IN THE MATING CAGE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863109 ↗
• InjuryDec 24, 2020Migration; Migration

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS AN ROI-C PLATE THAT MIGRATED OUT OF ITS MATING CAGE POST-OPERATIVELY. THE SUPERIOR PLATE WAS REMOVED BUT THE CAGE AND INFERIOR PLATE WERE NOT EXCHANGED SINCE THEY DID NOT MIGRATE. THE REPORTER RELATED THE SUPERIOR PLATE WAS DIFFICULT TO INSTALL DURING THE INITIAL PROCEDURE; THE STARTER AWL WAS USED AND THE PATIENT HAD HARD BONE. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 11072392 ↗
• MalfunctionJul 3, 2019Break; Break

  THIS MDR REPORT WAS SUBMITTED IN ERROR. THERE IS NO INFORMATION AVAILABLE THAT SUGGESTS THAT THERE WAS A MALFUNCTION OF THE DEVICE. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

  Patient problems: No Information

  MAUDE report 8757503 ↗
• MalfunctionJul 3, 2019Positioning Problem; Positioning Problem

  THIS MDR REPORT WAS SUBMITTED IN ERROR. THERE IS NO INFORMATION AVAILABLE THAT SUGGESTS THAT THERE WAS A MALFUNCTION OF THE DEVICE. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

  Patient problems: No Information

  MAUDE report 8757473 ↗