VerteGlide Spinal Growth Guidance System 00-1722-4530Recalls & reported problems

Orthopediatrics Corp. · VERTEGLIDE 4.5 POLYAXIAL PEDICLE SCREW 4.5MM X 30MM, CLOSED · Class 2 · Implant

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 00840194463508), received between Mar 3, 2026 and Mar 3, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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

Material Protrusion/Extrusion1

Patient problems

Failure of Implant1

Recent adverse event reports

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

MalfunctionMar 3, 2026Material Protrusion/Extrusion
PROMINENT HARDWARE: PATIENT PRESENTED WITH UPPER THORACIC SCREWS ON THE LEFT THAT ARE VISIBLE THROUGH SKIN.
Patient problems: Failure of Implant
MAUDE report 24498371 ↗

Device details

UDI-DI	`00840194463508`
Brand	VerteGlide Spinal Growth Guidance System
Model	00-1722-4530
Company	Orthopediatrics Corp.
Product code	PGM · Growing rod system
Class	Class 2
FDA submission	K241816
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Apr 8, 2025

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.

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