CD Horizon® Spinal System 55740004530Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 55740004530 5.5/6 MAS 4.5X30 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
- 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 00613994996718), received between May 18, 2023 and May 18, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Paraplegia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T4/L2 CORRECTIO N/FIXATION, INSERTION OF PS UNDER MAZOR FOR AIS. IT WAS REPORTED THAT AFTER INSERTION OF THE PS, IT WAS CONFIRMED THAT THE T9 LEFT, T5 RIGHT, AND T6 RIGHT OF THE PS WERE DEVIATED FROM THE SPINAL CANAL, AND THEN THEY WERE REMOVED. THE PATIENT EXPERIENCED PARALYSIS IN THE RIGHT LOWER LIMB. THERE WAS A DELAY IN THE PROCEDURE BY LESS THAN 60 MINS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Paraplegia
MAUDE report 16951384 ↗
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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