Luna 3D LUN3014-08Recalls & reported problems
Benvenue Medical, Inc. · 14mm, 8-Degree, Luna 3D Lordotic Implant Kit · Class 2
Data updated Oct 18, 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 00813478020353), received between Mar 16, 2017 and Mar 16, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Missing Value Reason” (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 18, 2026.
Most reported problems
Device problems
- Missing Value Reason1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2017Missing Value Reason; Missing Value Reason
DURING A FOLLOW-UP VISIT AT 17 WEEKS POST-OP ON (B)(6) 2017, RADIOGRAPHS REVEALED THAT A LUNA 14 MM LORDOTIC IMPLANT AT L5/S1 HAD DISASSEMBLED, WITH THE MIDDLE MIGRATING POSTERIORLY INTO THE SPINAL CANAL AND CREATING PAIN. THE PHYSICIAN DECIDED TO REVISE THAT LEVEL VIA AN ANTERIOR APPROACH.
Patient problems: Patient Problem/Medical Problem
MAUDE report 6410812 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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