CD Horizon® Spinal System 55740006540Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 55740006540 5.5/6 MAS 6.5X40 CC S · 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 00613994995148), received between Dec 22, 2021 and Dec 22, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Most reported problems
Device problems
- Device Dislodged or Dislocated2
Patient problems
- Fever2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2021 MPXR-901578 (FOR, REP, HCP): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PLIF SPINAL THERAPY AT L4/5 FOR LCS. IT WAS REPORTED THAT APPROXIMATELY 2MM THE CAGE BACKED OUT. AS AN ADDITIONAL SURGERY THE CAGE WAS REMOVED AND ILIUM INSERTED. THE SCREWS ON BOTH SIDES OF L5 BECAME LOOSE. THE PATIENT HAS A FEVER AND IS SUSPECTED OF BEING INFECTED. THERE WAS NO FURTHER INFORMATION REPORTED.
Patient problems: Fever
MAUDE report 13058556 ↗InjuryDec 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PLIF SPINAL THERAPY AT L4/5 FOR LCS. IT WAS REPORTED THAT APPROXIMATELY 2MM THE CAGE BACKED OUT. AS AN ADDITIONAL SURGERY THE CAGE WAS REMOVED AND ILIUM INSERTED. THE SCREWS ON BOTH SIDES OF L5 BECAME LOOSE. THE PATIENT HAS A FEVER AND IS SUSPECTED OF BEING INFECTED. THERE WAS NO FURTHER INFORMATION REPORTED.
Patient problems: Fever
MAUDE report 13058550 ↗
Other Appliance, fixation, spinal intervertebral body devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 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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