TLX 5902826P2Recalls & reported problems

Nuvasive, Inc. · TLX20, 8x11x26mm 20° · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517958365), received between Feb 15, 2021 and Feb 15, 2021 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Migration or Expulsion of Device1

Patient problems

Pain1

Recent adverse event reports

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

MalfunctionFeb 15, 2021Migration or Expulsion of Device; Migration or Expulsion of Device
A REVISION TOOK PLACE ON (B)(6) 2020 AND THE CAGE WAS REPLACED WITHOUT A REPORTED ISSUE. ON ANOTHER UNKNOWN DATE EXPERIENCING EXTREME PAIN AGAIN , RADIOGRAPHS AGAIN SHOW THE CAGE AT L2-3 HAD MIGRATED. ON (B)(6) 2021 A REVISION PROCEDURE WAS COMPLETED REPLACING THE CAGE AT L2-3 AND ADDING ADDITIONAL POSTERIOR FIXATION.
Patient problems: Pain
MAUDE report 11329980 ↗

Device details

UDI-DI	`00887517958365`
Brand	TLX
Model	5902826P2
Company	Nuvasive, Inc.
Product code	PHM · Intervertebral fusion device with bone graft, thoracic
Class	Class 2
FDA submission	K171633
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 14, 2025

Device type (GMDN): Metallic 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 in order 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 cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] 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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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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