MAUDE Adverse Event Report: Spinal Elements, Inc Lucent XP; LUMBAR INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT

Catalog Number	P11350-507
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, patient underwent plif surgery at l4-l5.Patient reported pain the following week.Radiograghs depicted posterior migration of the interbody implant.Revision surgery was performed on (b)(6) 2026 to remove the implant and replaced it with allograft.Reportedly the patient is currently doing well post revision.
Additional Manufacturer Narrative
Images provided on (b)(6) 2026 depicts an implant that appears to have migrated posteriorly to the back edge of the vertebral body.Based on the image (one week post-op) the number of threads exposed on the device's expansion screw assembly were the same as the intra-op confirmation images taken on (b)(6) 2026.This suggests the implant maintained its height and did not collapse/malfunction.Image of explant also confirms the device was expanded.Dhr review concluded that the product was inspected and accepted for use and met all specified parameters of the quality inspection process (qip) with no associated nonconformance.The returned portion of the device was visually inspected, measured and functionally tested.The device was received in a disassembled state with damage to the peek tip.The remains of the device otherwise meets dimensional specifications, except for the damaged tip which may have been caused during removal.Unknown factors include: the exact date of the migration between follow-ups, patient activity at the time or prior to the event, the degree of spinal instability, or patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma/fall was reported.) these factors dictate the ongoing stability and placement of the implant.Root cause of the migration cannot be determined.Labeling review notes: "possible adverse effects".3.Loss of fixation (implant migration).

• Brand Name: Lucent XP
• Common Device Name: LUMBAR INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT
• Manufacturer (Section D): Spinal Elements, Inc; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose drive; suite 200; carlsbad, CA 92010 ; +1(760)607-1565
• MDR Report Key: 50197048
• Report Number: 3004893332-2026-00005
• Device Sequence Number: 10436836
• Product Code: MAX
• UDI-Device Identifier: 00840606184861
• UDI-Public: (01)00840606184861(10)260056(11)260519
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K234150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: P11350-507
• Device Lot Number: 260056
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male