Lucent XP P11350-507Recalls & reported problems

Spinal Elements, Inc. · LUCENT XP® 10MM X 24MM X 7MM 5°-10° · Class 2 · Implant

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840606184861), received between Aug 10, 2026 and Aug 10, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Migration or Expulsion of Device1

Patient problems

Back pain1

Recent adverse event reports

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

InjuryAug 10, 2026Migration or Expulsion of Device
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.
Patient problems: Back pain
MAUDE report 50197048 ↗

Device details

UDI-DI	`00840606184861`
Brand	Lucent XP
Model	P11350-507
Company	Spinal Elements, Inc.
Product code	MAX · Intervertebral Fusion Device With Bone Graft, Lumbar
Class	Class 2
FDA submission	K234150
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 21, 2025

Device type (GMDN): Metal-polymer composite spinal interbody fusion cage

A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated device made of a non-bioabsorbable synthetic polymer with a metallic coating that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

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All Intervertebral Fusion Device With Bone Graft, Lumbar devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.