ROI-A IR2422PRecalls & reported problems
LDR Spine Usa, Inc. · ROI-A MEDIAN IMPLANT PXL 23X26 H10 6° · Class 2
All models of ROI-A (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03662663011068), received between Dec 21, 2020 and Dec 21, 2022 — classified as 1 injury, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture2
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2022Fracture; Fracture
IT WAS REPORTED THAT A ROI-A CAGE FRACTURED WHILE BEING IMPLANTED. IT REMAINS IMPLANTED, BUT THE PLATES WERE UNABLE TO BE INSTALLED. THERE WAS A DELAY OF 15 MINUTES, BUT THERE WERE NO REPORTED PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16023431 ↗MalfunctionMar 8, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY THE CAGE CRACKED WHILE THE PLATE WAS BEING INSTALLED. THE SURGEON REMOVED THE PLATE AND CAGE AND REPLACED THEM WITH ALTERNATES TO FINISH THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11436917 ↗InjuryDec 21, 2020Premature Separation; Premature Separation
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 TWO OF TWO FOR THIS EVENT.
Patient problems: No Code Available
MAUDE report 11047923 ↗
Other Spinal Vertebral Body Replacement Device devices
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- X-CORE 7220018Nuvasive, Inc. · 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
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7160012Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- 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 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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