CD Horizon™ ModuLeX™ Spinal System 559200014Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SET SCREW PK 559200014 STERILE B/OFF 2PK · 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 20763000435763), received between Nov 14, 2024 and Nov 14, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 Deformation1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionNov 14, 2024Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING AIS FUSION. IT WAS REPORTED THAT THE SET SCREWS WERE STRIPPED AND THE MODULAR HEAD WAS NOT WORKING PROPERLY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE EVENT OCCURRED BACK TABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20681629 ↗

Device details

UDI-DI	`20763000435763`
Brand	CD Horizon™ ModuLeX™ Spinal System
Model	559200014
Company	Medtronic Sofamor Danek, Inc.
Product code	NKB · Thoracolumbosacral pedicle screw system
Class	Class 2
FDA submission	K210637
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	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.

Other Thoracolumbosacral pedicle screw system devices

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Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
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EXPEDIUM VERSE 199721001S
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Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
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EXPEDIUM VERSE 199721000S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
97 reports

All Thoracolumbosacral pedicle screw system devices →

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