ROI-A IR2541PRecalls & reported problems
LDR Spine Usa, Inc. · ROI-A MEDIAN IMPLANT PXL 27X30 H12 14° · Class 2
- 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 03662663011419), received between Jul 3, 2019 and Apr 25, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture1
Patient problems
- No Information2
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2024Fracture; Fracture
IT WAS REPORTED THAT A ROI-A CAGE AND A ROI-A ANCHOR PLATE FRACTURED INTRA-OPERATIVELY. THERE WAS NO REPORTED PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY TO THE PROCEDURE. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19183238 ↗MalfunctionJul 3, 2019Break; Break
IT WAS REPORTED THAT DURING SURGERY, TWO ROI-A CAGES BROKE UPON INSERTION OF THE ANCHORING PLATE. THERE WAS NO REPORTED PATIENT OR SURGICAL IMPACT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 8757492 ↗MalfunctionJul 3, 2019Break; Break
IT WAS REPORTED THAT DURING SURGERY, TWO ROI-A CAGES BROKE UPON INSERTION OF THE ANCHORING PLATE. THERE WAS NO REPORTED PATIENT OR SURGICAL IMPACT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 8757467 ↗
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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.