ROI-A IR2543PRecalls & reported problems
LDR Spine Usa, Inc. · ROI-A MEDIAN IMPLANT PXL 27X30 H14 14° · Class 2
All models of ROI-A (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03662663011433), received between Nov 17, 2023 and Nov 17, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Migration1
Patient problems
- Numbness1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 2023Migration; Migration
IT WAS REPORTED THAT THE THREADS OF AN ROI-A CAGE INSERTER WERE DAMAGED AND WOULD NOT ATTACH TO A CAGE. A SECOND CAGE WAS OPENED TO CONFIRM THE PROBLEM WAS WITH THE THREADS OF THE INSERTER. THEREFORE, THE SURGEON DECIDED TO PLACE THE IMPLANT WITHOUT THE INSERTER. THEN THE CAGE DISCREETLY RECEDED WHEN THE ANCHORING PLATES WERE INSTALLED, CAUSING A POSSIBLE CONFLICT ON THE NERVE ROOT IN THE FORAMEN. THE PATIENT HAD NUMBNESS IN HER RIGHT LEG THE DAY AFTER SURGERY WHICH CONTINUED AFTER HER DISCHARGE FROM THE HOSPITAL, BUT SHE DID NOT LOSE MOTOR FUNCTION. THERE WAS A DELAY OF ABOUT 45 MINUTES TO THE PROCEDURE.
Patient problems: Numbness
MAUDE report 18162106 ↗
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
- IdentiTi 232-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall8 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page