ROI-A IR2009TRecalls & reported problems
LDR Spine Usa, Inc. · ROI-A ANCHORING PLATE S · 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 03662663010993), received between May 7, 2022 and Jun 4, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Malposition of Device1
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.
MalfunctionJun 4, 2026Fracture
IT WAS REPORTED THAT A ROI-A PLATE FRACTURED AT S1 INTRA-OPERATIVELY AND REMAINS IMPLANTED. THE PATIENT IS STABLE AND IS UNDER CLINICAL FOLLOW-UP WITH NO EVIDENCE OF SPACER MIGRATION AT THIS TIME. NO INTERVENTION IS CURRENTLY PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25399879 ↗MalfunctionMay 7, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED THAT DURING SURGERY, A PLATE BECAME MISALIGNED DURING INSTALLATION. THE PLATE WAS REMOVED AND REPLACED WITH ANOTHER PLATE TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OVER 30 MINUTES IN LENGTH, BUT THERE WE NO PATIENT IMPACTS REPORTED. DEVICE EVALUATION BY THE MANUFACTURER FOUND THAT THE PLATE WAS JAMMED INSIDE ITS MATING CAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14320378 ↗
Other Spinal Vertebral Body Replacement Device devices
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- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- 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.