CD Horizon® Spinal System 55740008580Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 55740008580 5.5/6 MAS 8.5X80 CC S · Class 2 · Implant
All models of CD HORIZON Spinal System (342)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994996497), received between Feb 23, 2018 and Feb 23, 2018 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2018Break; Break
IT WAS REPORTED THAT PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR DEGENERATIVE SCOLIOSIS AND UNDERWENT FUSION AT T10-S2AI. POST -OPERATIVELY, THE SCREW OF RIGHT S2AI WAS BROKEN. THE BROKEN PART WAS IN THE FRONT OF THE SACROILIAC JOINT. AND IT WAS THE SHAFT PART BROKEN WHICH WAS UNDER THE SCREW HEAD ABOUT 5MM. FRAGMENTS OF BROKEN PART REMAINS INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT. BECAUSE THERE WAS NO PAIN IN THE PATIENT, THE REOPERATION WAS NOT PLANNED TO BE PERFORMED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7291600 ↗
Other Appliance, fixation, spinal intervertebral body devices
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- 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
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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