TRANSITION 152.466SRecalls & reported problems

Globus Medical, Inc. · TRANSITION 6.5mm HA Polyaxial Pedicle Screw, 50mm · Class 2

Data updated Oct 13, 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 00849044009170), received between Mar 5, 2024 and Mar 5, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (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

Device Handling Problem1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionMar 5, 2024Device Handling Problem; Device Handling Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REPLACE TRANSITION SCREWS THAT WERE FOUND LOOSE POST-OPERATIVELY. THIS EVENT OCCURRED IN SWITZERLAND.
Patient problems: Insufficient Information
MAUDE report 18838073 ↗

Device details

UDI-DI	`00849044009170`
Brand	TRANSITION
Model	152.466S
Company	Globus Medical, Inc.
Product code	NQP · POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
Class	Class 2
FDA submission	K073439
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 2, 2025

Device type (GMDN): Trans-facet-screw internal spinal fixation system, sterile

A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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