CD HORIZON® Spinal System 1603200500Recalls & reported problems

Medtronic Sofamor Danek, Inc. · ROD 1603200500 6.0 TICP4 NS STR LN 500MM · 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: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994990686), received between Aug 27, 2026 and Aug 27, 2026 — classified as 2 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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryAug 27, 2026Break
Information was received from healthcare provider (HCP) via a manufacturer representative regarding a rod used for revision of two l evel Anterior Lumbar Interbody Fusion therapy and posterior hardware revision for pre-operative diagnosis of spinal stenosis. It was reported that the patient has had multiple procedures done. On (b)(6) 2019, the patient underwent an L3-L5 lumbar spinal fusion. On (b)(6) 2026, the patient had a revision extension spinal fusion spanning T10-Pelvis. Between this surgery and one month follow up on (b)(6) 2026, the patients rods broke just above the S1 screws. On (b)(6) 2026, the patient underwent a revision and had an Anterior Lumbar Interbody Fusion therapy done at L4-L5 and L5-S1 levels and then had a posterior revision where extra pelvic screws were added along with secondary rods for more support. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50470131 ↗
InjuryAug 27, 2026Break
Information was received from healthcare provider (HCP) via a manufacturer representative regarding a rod used for revision of two l evel Anterior Lumbar Interbody Fusion therapy and posterior hardware revision for pre-operative diagnosis of spinal stenosis. It was reported that the patient has had multiple procedures done. On (b)(6) 2019, the patient underwent an L3-L5 lumbar spinal fusion. On (b)(6) 2026, the patient had a revision extension spinal fusion spanning T10-Pelvis. between this surgery and one month follow up on (b)(6) 2026, the patients rods broke just above the S1 screws. On (b)(6) 2026, the patient underwent a revision and had an Anterior Lumbar Interbody Fusion therapy done at L4-L5 and L5-S1 levels and then had a posterior revision where extra pelvic screws were added along with secondary rods for more support. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50470106 ↗

Device details

UDI-DI	`00613994990686`
Brand	CD HORIZON® Spinal System
Model	1603200500
Company	Medtronic Sofamor Danek, Inc.
Product code	MNI · ORTHOSIS, SPINAL PEDICLE FIXATION
Class	Class 2
FDA submission	K121680
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	Aug 9, 2024

Device type (GMDN): Bone-screw internal spinal fixation system rod

An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

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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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