Luna 3D LUN3010-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813478020315), received between May 31, 2017 and Sep 19, 2017 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 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 SCHEDULED, WHERE A PHYSICIAN WAS TO REMOVE A LUNA IMPLANT THAT HAD MIGRATED POSTERIORLY. BASED ON THE IMAGING, THE IMPLANT WAS IN THE SPINAL CANAL. THE PATIENT WAS ASYMPTOMATIC AND PHYSICIAN CALLED IT AN INCIDENTAL FINDING. REVISION SURGERY SCHEDULED FOR (B)(6) 2017. THE REVISION SURGERY WAS UNEVENTFUL AND THE PHYSICIAN ONLY REMOVED THE MIDDLE MEMBER WHICH WAS PROTRUDING INTO THE SPINAL CANAL. AS INDICATED BY PHYSICIAN THE OUTER IMPLANT MEMBERS WERE STARTING TO FUSE AND ULTIMATELY DECIDED TO LEAVE THEM IMPLANTED. NO OTHER COMPLICATIONS OR POST-OPERATION ISSUES WERE MENTIONED.

  Patient problems: No Code Available

  MAUDE report 6877551 ↗
• InjuryMay 31, 2017Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  ON MAY 5, 2017, THE COMPANY BECAME AWARE OF A REVISION SURGERY SCHEDULED, WHERE PHYSICIAN WOULD BE REMOVING TWO (2) LUNA IMPLANTS THAT HAD MIGRATED POSTERIORLY. BASED ON IMAGING, THE IMPLANT AT L4/5 IS IN THE CANAL, AND THE OTHER AT L5/S1 IS IMPINGING UPON THE L5 NERVE ROOT. THE PATIENT HAD LEG PAIN, LOSS OF STRENGTH AND NUMBNESS, AS WELL AS A FOOT DROP. REVISION SURGERY SCHEDULED FOR (B)(6) 2017. PHYSICIAN INDICATED THAT A SPINOUS PROCESS PLATE WAS PRESENT FOR POSTERIOR FIXATION AT L4/5, BUT THAT IT WAS NOT ENGAGING THE L4 SPINOUS PROCESS. PHYSICIAN ALSO INDICATED THAT NO POSTERIOR FIXATION WAS PRESENT AT L5/S1.

  Patient problems: Pain

  MAUDE report 6603462 ↗