Luna 3D LUN3013-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813478020346), received between Dec 21, 2017 and Dec 21, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2017Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  ON (B)(6) 2017, THE COMPANY BECAME AWARE OF A REVISION SURGERY PERFORMED THAT DAY DUE TO PATIENT EXPERIENCING INCREASED SYMPTOMATIC PAIN. IT WAS FURTHER LEARNED THAT THE ORIGINAL CASE WAS COMPLETED ON (B)(6) 2017. BASED ON PROVIDED IMAGES, IT APPEARS THAT THE LUNA DEVICE HAD SLIGHTLY MIGRATED POSTERIORLY AT THE FIRST FOLLOW-UP AT 1-MONTH POST-OP. AT AROUND THE 6-MONTHS POST-OPERATION FOLLOW-UP, THE PATIENT EXPERIENCED A FALL WITH INCREASED SYMPTOMATIC RADICULOPATHY PAIN. AT THAT TIME, IMAGING SHOWED THAT THE MIDDLE MEMBER OF THE LUNA DEVICE HAD PARTIALLY DISASSEMBLED AND FURTHER MIGRATED POSTERIORLY INTO THE SPINAL CANAL. DURING THE REVISION SURGERY, THE IMPLANT WAS NOT SAFELY RETRIEVABLE AND AS A CONSEQUENCE, IT WAS LEFT IN PLACE AND FURTHER BONY DECOMPRESSION AROUND THE CANAL WAS PERFORMED. PROCEDURE CONTINUED SUCCESSFULLY WITH NO OTHER ISSUES. NO FLUORO WAS TAKEN ON DAY OF REVISION.

  Patient problems: Pain

  MAUDE report 7141406 ↗