CD HORIZON® ASTUTE™ SPINAL SYSTEM 1608451035Recalls & reported problems

Medtronic Sofamor Danek, Inc. · PEEK ROD 1608451035 6.0 X 6.9MM STR 35MM · Class 2 · Implant

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169281110), received between Dec 26, 2025 and Dec 26, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Break1

Patient problems

Pain1

Recent adverse event reports

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

InjuryDec 26, 2025Break; Break
EVENT OCCURRED POST A LUMBAR POSTERIOR FUSION PROCEDURE.
Patient problems: Pain
MAUDE report 23894857 ↗

Device details

UDI-DI	`00643169281110`
Brand	CD HORIZON® ASTUTE™ SPINAL SYSTEM
Model	1608451035
Company	Medtronic Sofamor Danek, Inc.
Product code	NQP · POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
Class	Class 2
FDA submission	K191066
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	Aug 12, 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.

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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