CD HORIZON® Spinal System 54740106530Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 54740106530 4.75 HA MAS 6.5X30 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 00613994976765), 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 21321578 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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