ROI-A IR2433PRecalls & reported problems
LDR Spine Usa, Inc. · ROI-A MEDIAN IMPLANT PXL 23X26 H12 10° · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662663011136), received between May 9, 2022 and Sep 8, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
Device problems
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2023Fracture; Fracture
IT WAS REPORTED THAT A PATIENT HAD ALIF SURGERY AND HAD A MEDIAN ROI-A DEVICE IMPLANTED IN THE SPINE. AFTER THE SURGERY AND CHECKUP WITH X-RAYS, IT WAS SHOWN THAT ONE OF THE BLADES ON THE DEVICE WAS FRACTURED IN HALF. THERE WAS NO REPORTED PATIENT IMPACT AND THE IMPLANT REMAINS IMPLANTED WITH NO REVISION SURGERY PLANNED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17711770 ↗MalfunctionMay 9, 2022Fracture; Fracture
IT WAS REPORTED THAT UPON MALLETING THE IMPLANT INTO THE PATIENT'S LUMBAR SPINE AT L5-S1, THE CAGE CRACKED AND A PIECE BROKE AT THE POINT OF ATTACHMENT IN THE AREA OF THE THREADED ROD; THE FRACTURED PIECE WAS RECOVERED. THE IMPLANT AND FIRST PLATE WERE REMOVED AND NEW ONES WERE PLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14337382 ↗
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- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.