ROI-A IR2007TRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03662663010979), received between May 28, 2019 and Oct 31, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT HAD A RETURN OF PAIN IN THE LOWER SPINE AND RADIATING DOWN THE LEGS THREE MONTHS POST-OPERATIVELY. ADDITIONAL PAIN MEDICATION DID NOT IMPROVE THE PATIENT'S SYMPTOMS. A FOLLOW-UP RADIOLOGICAL STUDY SHOWED FINDINGS CONSISTENT WITH PSEUDOARTHROSIS, SEGMENTAL VERTEBRAL INSTABILITY, AND CAGE DISPLACEMENT AT THE SURGICAL SITE (L4/L5 SEGMENT). ADDITIONALLY, AN ANCHORING PLATE WAS FRACTURED. A REVISION SURGERY WAS PERFORMED TO ADD A TWO-LEVEL POSTERIOR MIS SCREW CONSTRUCT TO L4/L5. THE IMPLANT WILL NOT BE REMOVED, AND THE PATIENT IS NOW DOING WELL AND WITHOUT PAIN. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Inadequate Osseointegration; Neuralgia; Pain

  MAUDE report 23438057 ↗
• MalfunctionJul 15, 2019Positioning Problem; Positioning Problem

  ROI-A: BROKEN CAGE. IMPLANTATION OF A ROI-A INSET CAGE AFTER METAL REMOVAL OF A SYNFIX CAGE FROM DEPUY SPINE IN L5-S1. WHEN INSERTING THE ANCHOR PLATES, THE ROI-A IS BROKEN AT THE ATTACHMENT INTERFACE TO THE CAGE HOLDER. WHETHER THE CAGE IS BROKEN WHEN LOOKING UP THE ANCHOR PLATES OR WHEN INSERTING. NO PATIENT IMPACT OR SERIOUS DELAY WAS REPORT . ADDITIONAL INFORMATION WAS RECEIVED ON JULY 5TH: ACCORDING TO THE REPORTER , THE PATIENT HAD NOT HARD BONES AND THE STARTER AWL WAS NOT USED TO PREPARE THE ANCHORING PLATE INSERTION. THE CAGE BROKE AFTER IMPLANTATION OF THE SECOND ANCHOR. ALSO , THE CAGE WAS PROPERLY ASSEMBLED WITH THE HOLDER. ACCORDING TO VISUAL INSPECTION, IT WAS MOUNTED CORRECTLY. IT MAY BE POSSIBLE THAT THE CAGE HAS BEEN MOUNTED INCORRECTLY. SINCE THE CAGE-HOLDER ACCORDING TO X-RAY HAD SHIFTED SLIGHTLY AT THE FINAL IMPACT. THE AXIS OF THE DISC SPACE WAS RESPECTED , AND THE SURGICAL TECHNIQUE WAS RESPECTED FOR ANCHORING PLATE IMPACTION SEQUENCE (USE OF IMPACTOR #1 THEN IMPACTOR #2) . THE FIRST ANCHORING PLATE WAS FULLY SEATED . ACCORDING TO THE REPORTER , IT'S NOT POSSIBLE THAT TWO ANCHORS WERE IMPLANTED IN THE SAME SLOT . INVESTIGATION ONGOING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8788298 ↗
• MalfunctionMay 28, 2019Positioning Problem; Device Handling Problem; Positioning Problem; Device Handling Problem

  ROI-A : BROKEN CAGE DURING INSERTION OF THE CAGE DUE TO HARD BONE. AS REPORTED, UPON INSERTING THE FIRST BLADE INTO THE S1 BODY, SURGEON HAD TO USE EXCESSIVE FORCE AS PATIENT BONE WAS HARDER THAN PREVIOUSLY THOUGHT. THE IMPACT BROKE THE FACE OF THE CAGE. NO EFFECT ON PATIENT. IT WAS REMOVED EASILY AND REPLACED WHILE SAME SIZE CAGE BUT SMALLER PLATES. THE STARTER AWL WAS UTILIZED IN SECOND CAGE. NO SURGERY DELAY WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON MAY 20TH 2019: PATIENT IS FINE. X-RAYS ARE NOT AVAILABLE. SURGERY WAS COMPLETED BY USING/OPENING A 2ND IMPANT. THE CAGE WAS PROPERLY ASSEMBLED WITH THE HOLDER. ADDITIONAL INFORMATION WAS RECEIVED ON MAY 21ST 2019: THE STARTER AWL WAS NOT USED ON THE FIRST CAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8645077 ↗