Luna 3D LUN3012-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813478020339), received between Mar 7, 2017 and Sep 11, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Unintended Movement” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON AUGUST 12, 2019, BENVENUE RECEIVED INFORMATION INDICATING THAT A REVISION SURGERY TOOK PLACE TO REMOVE A LUNA IMPLANT DUE TO PAIN. DATE OF INDEX SURGERY WAS (B)(6) 2017. REVISION SURGERY DATE IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 8997517 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem; Unintended Movement; Migration; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Migration

  ON (B)(6) 2017, THE COMPANY BECAME AWARE OF A REVISION SURGERY PERFORMED THAT DAY DUE TO PATIENT EXPERIENCING SEVERE PAIN. IT WAS FURTHER LEARNED THAT THE ORIGINAL CASE WAS COMPLETED ON (B)(6) 2017. ON (B)(6) 2017, 2-MONTH POST-OP, THE PATIENT PRESENTED IN THE ER WITH SEVERE PAIN DOWN HIS RIGHT LEG. CT SCAN SHOWED THAT A PORTION OF THE IMPLANT HAD MIGRATED POSTERIORLY INTO THE SPINAL CANAL. THE SURGEON SCHEDULED A REVISION SURGERY ON THE FOLLOWING DAY TO REMOVE THE IMPLANT. DURING THE REVISION SURGERY, THE IMPLANT COULD NOT BE SAFELY REMOVED AS IT WAS TOO MEDIAL AND UNDER THE DURA. THE SURGEON PERFORMED FORAMINOTOMIES TO CREATE MORE SPACE FOR THE NERVE ROOTS. PATIENT IS DOING OKAY ONE DAY POST-OP FOLLOW-UP.

  Patient problems: Pain

  MAUDE report 7168889 ↗
• InjuryMay 25, 2017Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  ON (B)(4) 2017, THE COMPANY BECAME AWARE OF A LUNA DEVICE DISASSEMBLED POST-OPERATIVELY AND THE MIDDLE MEMBER MIGRATED POSTERIORLY. DISASSEMBLY AND SUBSEQUENT MIGRATION OCCURRED SOMETIME BETWEEN THE ORIGINAL CASE AND 6-WEEKS POST-OP. AT THE TIME OF THE EVENT, REVISION SURGERY WAS TO BE DETERMINED. SINCE THE MIGRATION WAS CAUSING THE PATIENT PAIN, REVISION SURGERY WAS SCHEDULED AND COMPLETED ON (B)(6) 2017. IMPLANT WAS REMOVED SUCCESSFULLY AND REPLACED BY ANOTHER LUNA DEVICE AT THE SAME LEVEL. ALL SYMPTOMS RETURNED TO NORMAL POST RE-OPERATION.

  Patient problems: Pain

  MAUDE report 6590058 ↗
• InjuryMar 8, 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 WAS MADE AWARE THAT IN A FOLLOW-UP RADIOGRAPHIC EXAM AT 8 WEEKS POST-OP OF A PATIENT THAT HAD A FUSION SURGERY WHERE THE LUNA IMPLANT WAS USED, REVEALED THAT THE LUNA 12MM LORDOTIC IMPLANT HAD DISASSEMBLED, WITH THE MIDDLE MIGRATING POSTERIORLY INTO THE SPINAL CANAL. SINCE THE MIGRATION WAS CAUSING THE PATIENT SIGNIFICANT PAIN, REVISION SURGERY WAS SCHEDULED. NO ADDITIONAL INFORMATION WERE PROVIDED AT THAT TIME AND THE COMPANY IS SEEKING ADDITIONAL INFORMATION.

  Patient problems: Pain

  MAUDE report 6389239 ↗
• InjuryMar 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  'FOLLOW-UP RADIOGRAPHS AT 13 WEEKS POST-OP ON (B)(6) 2017 REVEALED THAT THE LUNA 12 MM LORDOTIC IMPLANT HAD DISASSEMBLED, WITH THE MIDDLE MIGRATING POSTERIORLY INTO THE SPINAL CANAL. SINCE THE MIGRATION WAS CAUSING THE PATIENT SIGNIFICANT PAIN, REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2017. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 WITH (B)(6) IN ATTENDANCE. REMOVAL OF THE IMPLANT PROVED DIFFICULT AS THE MIDDLE COMPONENT HAD MOVED POSTERIORLY AND ACROSS MIDLINE INTO THE SPINAL CANAL. THE SURGEON COULD NOT EASILY ACCESS THE LOCK SCREW AND WAS UNABLE TO REMOVE IT FROM THE DEVICE IN ORDER TO ATTACH THE EXTRACTOR TOOL FOR REMOVAL. THE SURGEON THEREFORE HAD TO USE KOCHER FORCEPS TO GRAB THE MIDDLE AND PULL IT FROM THE PATIENT. IN DOING SO, A DURAL TEAR OCCURRED WHICH REQUIRED FURTHER INTERVENTION TO REPAIR. THE OUTER COMPONENTS PROVED DIFFICULT TO REMOVE AS WELL. BECAUSE OF THE DURAL TEAR AND THE CONDITION OF THE PATIENT, THE SURGEON DECIDED TO ABANDON FURTHER EFFORTS TO REMOVE THE REMAINDER OF THE IMPLANT AND REPLACE WITH ANOTHER DEVICE, THEREBY LEAVING THE SPACE IN ITS COLLAPSED STATE. THE PATIENT MAY REQUIRE FURTHER INTERVENTION FROM AN ALTERNATE APPROACH (I.E. ANTERIOR) IN ORDE

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6385577 ↗