CD HORIZON® Spinal System X0311334Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SCREW X0311334 LEG 5.5 G4 MAS TI 8.5X80 · Class 2 · Implant

All models of CD HORIZON Spinal System (342)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 6
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169015104), received between Dec 28, 2017 and Dec 29, 2017 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Operational Issue” (6 reports).

4 other recalls cover devices cleared under the same FDA submission (K042025); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Device problems

Device Operational Issue6

Patient problems

Pain6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

InjuryDec 29, 2017Device Operational Issue; Device Operational Issue
IT WAS REPORTED THAT AN UNKNOWN DATE PATIENT UNDERWENT SPINAL FUSION SURGERY AT SACRAL- ILIAC. POST-OPERATIVELY, IT WAS REPORTED THAT SCREW SEEMED TO BE LOOSENING FROM THEIR SET SCREW. THE SET SCREW IS NO LONGER LOCKED IN THE SCREW TULIP, ALLOWING THE ROD TO BE FREE MOVING. AS A RESULT, PAIN WAS OBSERVED IN THE PATIENT.
Patient problems: Pain
MAUDE report 7153738 ↗
InjuryDec 29, 2017Device Operational Issue; Device Operational Issue
IT WAS REPORTED THAT AN UNKNOWN DATE PATIENT UNDERWENT SPINAL FUSION SURGERY AT SACRAL- ILIAC. POST-OPERATIVELY, IT WAS REPORTED THAT SCREW SEEMED TO BE LOOSENING FROM THEIR SET SCREW. THE SET SCREW IS NO LONGER LOCKED IN THE SCREW TULIP, ALLOWING THE ROD TO BE FREE MOVING. AS A RESULT, PAIN WAS OBSERVED IN THE PATIENT.
Patient problems: Pain
MAUDE report 7153737 ↗
InjuryDec 28, 2017Device Operational Issue; Device Operational Issue
IT WAS REPORTED THAT ON AN UNKNOWN DATE PATIENT UNDERWENT SPINAL FUSION SURGERY AT S2 TRANS-SACRAL. POST OPERATIVELY, IT WAS REPORTED THAT THE SCREW SEEMED TO BE LOOSENING ITS SET SCREW. PATIENT SUFFERED WITH PAIN AS A RESULT OF THE EVENT.
Patient problems: Pain
MAUDE report 7153727 ↗
InjuryDec 28, 2017Device Operational Issue; Device Operational Issue
IT WAS REPORTED THAT ON AN UNKNOWN DATE PATIENT UNDERWENT SPINAL FUSION SURGERY AT S2 TRANS-SACRAL. POST-OPERATIVELY , IT WAS REPORTED THAT THE SCREW SEEMED TO BE LOOSENING ITS SET SCREW. PATIENT SUFFERED WITH PAIN AS A RESULT OF THE EVENT.
Patient problems: Pain
MAUDE report 7153722 ↗
InjuryDec 28, 2017Device Operational Issue; Device Operational Issue
IT WAS REPORTED THAT ON AN UNKNOWN DATE PATIENT UNDERWENT SPINAL FUSION SURGERY AT SACRAL- ILIAC. POST-OPERATIVELY, IT WAS REPORTED THAT THE SCREW SEEM TO BE LOOSENING ITS SET SCREW. THE SET SCREW IS NO LONGER LOCKED IN THE SCREW TULIP, ALLOWING THE ROD TO BE FREE. PATIENT SUFFERED WITH PAIN AS A RESULT OF THE EVENT.
Patient problems: Pain
MAUDE report 7150491 ↗
InjuryDec 28, 2017Device Operational Issue; Device Operational Issue
IT WAS REPORTED THAT ON AN UNKNOWN DATE PATIENT UNDERWENT SPINAL FUSION SURGERY AT SACRAL- ILIAC. POST-OPERATIVELY, IT WAS REPORTED THAT THE SCREW SEEM TO BE LOOSENING ITS SET SCREW. THE SET SCREW IS NO LONGER LOCKED IN THE SCREW TULIP, ALLOWING THE ROD TO BE FREE. PATIENT SUFFERED WITH PAIN AS A RESULT OF THE EVENT.
Patient problems: Pain
MAUDE report 7150487 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042025. One submission often covers many models, so check the product and lot details in each record.

Z-0464-2012 · Nov 30, 2011 · Terminated
CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X0809439, Rx only, Medtronic Sofamor Danek USA, 1800
Z-0465-2012 · Nov 30, 2011 · Terminated
CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Py
Z-2878-2011 · Jun 28, 2011 · Terminated
ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilizat
Z-2875-2011 · Jun 28, 2011 · Terminated
CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization a

Device details

UDI-DI	`00643169015104`
Brand	CD HORIZON® Spinal System
Model	X0311334
Company	Medtronic Sofamor Danek, Inc.
Product code	MNI · ORTHOSIS, SPINAL PEDICLE FIXATION
Class	Class 2
FDA submission	K042025
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.

Other ORTHOSIS, SPINAL PEDICLE FIXATION devices

NA 04.614.508
Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION
277 reports
CREO 1134.0010
Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
112 reports
CREO 1119.0010
Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
80 reports
VIPER 186731745
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
43 reports
CD HORIZON® Spinal System 1553201090
Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
38 reports
EXPEDIUM 179902000
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
37 reports
CD HORIZON® Spinal System 7540220
Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
36 reports
EXPEDIUM VERSE 199721640
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
35 reports

All ORTHOSIS, SPINAL PEDICLE FIXATION 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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