CD HORIZON® Spinal System 7225545Recalls & reported problems

Medtronic Sofamor Danek, Inc. · CDH LEGACY PEEK 7225545 MAS 5.5X45 · Class 2 · Implant

All models of CD HORIZON Spinal System (342)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885074362762), received between Jan 16, 2017 and Jul 12, 2017 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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.

Most reported problems

Device problems

Appropriate Device Problem Term/Code Not Available2
Break2

Patient problems

No Code Available4
Pain4
Increased Sensitivity2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

InjuryJul 12, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH PEDICLE SCREWS AT L4-5. POST-OP, PAIN WAS CONFIRMED BY DIAGNOSTIC INJECTION TO BE COMING FROM THE PEDICLE SCREWS AT LEFT L4 <(>&<)> L5 AND ONE L5 PEDICLE SCREW WAS LOOSE. THE SCREW WAS EXPLANTED IN THE REVISION SURGERY.
Patient problems: No Code Available; Pain
MAUDE report 6705065 ↗
InjuryJul 12, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH PEDICLE SCREWS AT L4-5. POST-OP, PAIN WAS CONFIRMED BY DIAGNOSTIC INJECTION TO BE COMING FROM THE PEDICLE SCREWS AT LEFT L4 <(>&<)> L5 AND ONE L5 PEDICLE SCREW WAS LOOSE. THE SCREW WAS EXPLANTED IN THE REVISION SURGERY.
Patient problems: No Code Available; Pain
MAUDE report 6705064 ↗
InjuryJan 17, 2017Break; Break
PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION LEVELS: L4-5, L5-S1 IT WAS REPORTED VIA A MEDWATCH FORM THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION WITH A WIDE DECOMPRESSION AND POS TERIOR INSTRUMENTATION WITH PEDICLE SCREW AND ROD SYSTEMS. POST-OP, THE PATIENT COMPLAINED OF CONTINUOUS PAIN AND TENDERNESS OF LUMBAR SPINE. THE PATIENT UNDERWENT CT WHICH SHOWED THAT THE BACK HAD NOT FUSED AFTER THE SURGERY AND HE HAD TWO BROKEN PEDICLE SCREWS AT S1. THE PATIENT UNDERWENT REMOVAL OF HARDWARE.
Patient problems: Increased Sensitivity; No Code Available; Pain
MAUDE report 6255564 ↗
InjuryJan 16, 2017Break; Break
PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION LEVELS: L4-5, L5-S1 IT WAS REPORTED VIA A MEDWATCH FORM THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION WITH A WIDE DECOMPRESSION AND POSTERIOR INSTRUMENTATION WITH PEDICLE SCREW AND ROD SYSTEMS. POST-OP, THE PATIENT COMPLAINED OF CONTINUOUS PAIN AND TENDERNESS OF LUMBAR SPINE. THE PATIENT UNDERWENT CT WHICH SHOWED THAT THE BACK HAD NOT FUSED AFTER THE SURGERY AND HE HAD TWO BROKEN PEDICLE SCREWS AT S1. THE PATIENT UNDERWENT REMOVAL OF HARDWARE.
Patient problems: Increased Sensitivity; No Code Available; Pain
MAUDE report 6253047 ↗

Device details

UDI-DI	`00885074362762`
Brand	CD HORIZON® Spinal System
Model	7225545
Company	Medtronic Sofamor Danek, Inc.
Product code	KWP · APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Class	Class 2
FDA submission	K050809, K182928
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.

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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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