IDENTITI 100-08186010-SRecalls & reported problems

Alphatec Spine, Inc. · IDENTITi LIF POROUS Ti SPACER, 8 x 18 x 60 mm, 10° · Class 2 · Implant

All models of IdentiTi (31)

Data updated Oct 18, 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 00190376205076), received between Sep 18, 2024 and Sep 18, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Break1

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.

MalfunctionSep 18, 2024Break; Break
DURING THE 3-MONTH POSTOPERATIVE VISIT, THE PATIENT UNDERWENT A CT SCAN WHICH REVEALED THE SPACER WHICH WAS IMPLANTED AT L3-4 HAD BROKEN IN TWO PLACES. THE PATIENT IS EXPERIENCING PAIN. NO ADDITIONAL ACTION HAS BEEN TAKEN AT THIS TIME.
Patient problems: Pain
MAUDE report 20250038 ↗

Device details

UDI-DI	`00190376205076`
Brand	IDENTITI
Model	100-08186010-S
Company	Alphatec Spine, Inc.
Product code	PHM · Intervertebral fusion device with bone graft, thoracic
Class	Class 2
FDA submission	K191311
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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All Intervertebral fusion device with bone graft, thoracic devices →

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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