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Luna 3D LUN3011-08Recalls & reported problems

Benvenue Medical, Inc. · 11mm, 8-Degree, Luna 3D Lordotic Implant Kit · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813478020322), received between Sep 27, 2016 and Feb 20, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (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 18, 2026.

Most reported problems

Device problems

  • Migration2
  • Adverse Event Without Identified Device or Use Problem1
  • Unintended Movement1

Patient problems

  • Pain3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 20, 2019Migration; Migration

    ON (B)(6) 2019, BENVENUE RECEIVED INFORMATION OF A LUNA THAT DISASSEMBLED AND MIGRATED CAUSING PAIN. ORIGINAL DATE OF SURGERY WAS (B)(6) 2018. REVISION SURGERY WAS PERFORMED ON (B)(6) 2019.

    Patient problems: Pain

    MAUDE report 8356172 ↗
  • InjuryJan 25, 2019Migration; Migration

    ON JANUARY 3, 2019, BENVENUE RECEIVED INFORMATION OF A PATIENT WITH AN INDEX SURGERY OF (B)(6) 2018 HAD A SEVERE FALL RECENTLY THAT LED TO PAIN AND IMPLANT MIGRATION THAT WAS RESOLVED UNEVENTFULLY VIA AN ALIF APPROACH ON (B)(6) 2018. THE REMOVED IMPLANT WAS RETAINED BY THE HOSPITAL.

    Patient problems: Pain

    MAUDE report 8278788 ↗
  • InjurySep 27, 2016Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

    THE INITIAL LUNA PROCEDURE WAS PERFORMED UNEVENTFULLY FOR THE L4/5 LEVEL AND NO DEVICE MALFUNCTION WAS REPORTED. PAST TWO MONTH POST-OP, PATIENT RECURRING PAIN WAS REPORTED. FOLLOW-UP IMAGING REVEALED THAT THE IMPLANT WAS POSITIONED ANTERIORLY, AND A REVISION PROCEDURE WAS SCHEDULED. THE REOPERATION WAS UNEVENTFUL AND THE DEVICE WAS EXPLANTED AND REPLACED WITH A CAGE FROM ANOTHER MANUFACTURER VIA AN ANTERIOR APPROACH. PRODUCT WAS NOT RETURNED FOR INVESTIGATION BUT PHOTOS PROVIDED ILLUSTRATED THAT THE IMPLANT WAS INTACT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Patient problems: Pain

    MAUDE report 5982274 ↗

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Sources and updates

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