Invictus 19000-40-18Recalls & reported problems

Alphatec Spine, Inc. · POLYAXIAL SCREW, 4.0mm X 18mm · Class 2 · Implant

All models of Invictus (96)

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 00190376302911), received between Feb 21, 2025 and Feb 21, 2025 — 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
Material Separation1

Patient problems

Failure of Implant1
Insufficient Information1

Recent adverse event reports

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

MalfunctionFeb 21, 2025Break; Material Separation; Break; Material Separation
IN (B)(6) 2024, A PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION PROCEDURE AT LEVELS C1-C2. AROUND 3 MONTHS POSTOPERATIVELY, A RADIOGRAPH IMAGE REVEALED A SCREW AT C2 HAD BROKEN AT THE NECK.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 21435983 ↗

Device details

UDI-DI	`00190376302911`
Brand	Invictus
Model	19000-40-18
Company	Alphatec Spine, Inc.
Product code	NKG · Posterior cervical screw system
Class	Class 2
FDA submission	K203125
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	Sep 11, 2024

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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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