ROI-A IR2641PRecalls & reported problems
LDR Spine Usa, Inc. · ROI-A MEDIAN IMPLANT PXL 30X33 H14 14° · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03662663011723), received between May 18, 2021 and Aug 18, 2023 — classified as 3 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
- Crack1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING THE IMPACTION OF THE 1ST ANCHOR, THE ROI-A CAGE GOT BROKEN. THERE WAS A 20 MINUTE DELAY TO THE PROCEDURE TO INSTALL A NEW IMPLANT, AND NO REPORTED PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17571979 ↗MalfunctionDec 31, 2021Crack; Crack
IT WAS REPORTED A CRACK WAS FOUND AFTER PLACING A ROI-A CAGE; THE CAGE WAS REMOVED AND THERE WAS NO REPORTED PATIENT HARM OR INJURY; HOWEVER, THE TIME OF THE OPERATION WAS TEMPORARILY LENGTHENED TO REPLACE THE CAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13125371 ↗MalfunctionMay 18, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT WHEN TRYING TO IMPACT AN ANCHORING PLATE, THE IMPLANT HOLDER BECAME DISENGAGED FROM THE IMPLANT AND IT WAS IMPOSSIBLE TO REPOSITION THE IMPLANT HOLDER ON THE CAGE. THE CAGE FRACTURED. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11842153 ↗
Other Intervertebral Fusion Device With Integrated Fixation, Lumbar devices
- PIVOX™ Oblique Lateral Spinal System 2161001Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, lumbar182 reports
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- IdentiTi 232-10-85-250Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall5 reports
- IdentiTi 132-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall3 reports
- IdentiTi 232-10-85-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall2 reports
- MectaLIF Anterior 03.30.301Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall2 reports
- IdentiTi 232-11-90-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall1 report
- MectaLIF Anterior 03.30.300Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
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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