CD HORIZON® Spinal System 54740106535Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 54740106535 4.75 HA MAS 6.5X35 CC · 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
- 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 00613994976758), received between Feb 6, 2025 and Feb 6, 2025 — classified as 1 injury.
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
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.
InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID: (B)(4), STUDY ID: (B)(4), INCIDENT TYPE AE SUBEVENT NUMBER: 0. PRIMARY DIAGNOSIS: STENOSIS DESCRIPTION: LOW BACK PAIN ONSET DATE: ON (B)(6) 2024. INTERVENTIONS: ACTION SUBTYPE: DENERVATION PROCEDURE ACTION RESULT: YES ACTION DATE: ON (B)(6) 2024, DENERVATION PROCEDURE TYPE: RADIOFREQUENCY ABLATION ACTION SUBTYPE: AE RESULT IN HOSPITALIZATION ACTION RESULT: NO ACTION SUBTYPE: ANY OTHER ACTION(S) TAKEN ACTION RESULT: NO ACTION SUBTYPE: DID THE AE RESULT IN ANY TREATMENT ACTION RESULT: YES, ACTION SUBTYPE: DRUG THERAPY ACTION RESULT: YES, ACTION SUBTYPE: INJECTION ACTION RESULT: YES, INJECTION-1: INJECTION NAME: MEDIAL BRANCH BLOCK DATE: ON (B)(6) 2024, LEVELS: L3-L4 DETAILS: DIAGNOSTIC INJECTION-2: INJECTION NAME: MEDIAL BRANCH BLOCK DATE: ON (B)(6) 2024, LEVELS: L3-L4 DETAILS: DIAGNOSTIC PATIENT OUTCOME: RECOVERING/RESOLVING DIAGNOSTIC: ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: WERE ANY DIAGNOSTIC TEST PERFORMED ACTION RESULT: NO ADVERSE EVENT INFO: DOES THE ADVERSE EVENT INVOLVE A LUMBOSACRAL SPINAL LEVEL: YES, IF YES, LEVELS INVOLVED: L3-L4 SITE SERIOUSNESS ASSESSMENT:
Patient problems: Pain
MAUDE report 21321535 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
- CD HORIZON® Spinal System 5540030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis230 reports
- CD HORIZON® Spinal System 7578302Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis122 reports
- EXPEDIUM 179762480Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis114 reports
- ReLine 13550000Nuvasive, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis55 reports
- CD HORIZON® Spinal System 5440030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis50 reports
- EXPEDIUM 179712640Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis28 reports
- EXPEDIUM VIPER 196789300Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
- EXPEDIUM 179788635Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
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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