Luna 3D LUN3015-08Recalls & reported problems
Benvenue Medical, Inc. · 15mm, 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 00813478020360), received between Jan 11, 2018 and Jan 11, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 11, 2018Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2017, THE COMPANY BECAME AWARE OF A REVISION SURGERY PERFORMED THAT SAME DAY TO REMOVE AN IMPLANT THAT HAD DISASSEMBLED AND MIGRATED POSTERIORLY. THE ORIGINAL CASE WAS COMPLETED ON (B)(6) 2017. FOLLOW THE ORIGINAL SURGERY, PATIENT PRESENTED WITH CONTINUED RIGHT LEG PAIN. STANDARD X-RAYS SHOWED THE MIDDLE MEMBER COMPONENT HAS DISPLACED. DURING THE REVISION SURGERY, THE IMPLANT WAS REMOVED SAFELY WITHOUT INCIDENT. INTRA-OP FLUORO WAS TAKEN ON DAY OF REVISION.
Patient problems: Pain
MAUDE report 7184637 ↗
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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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