CD HORIZON® Spinal System 54840045540Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 54840045540 4.75 ATS MAS 5.5X40 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169438736), received between Mar 27, 2019 and Mar 27, 2019 — 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 16, 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.
MalfunctionMar 27, 2019Break; Break
PROCEDURE- SCHEDULED AS A L4-5 FUSION, THE SURGEON ENDED UP DOING A L3-5 FUSION LEVELS IMPLANTED: L4-5 IT WAS REPORTED THAT INTRA-OP, THE SCREW WAS BROKEN WHILE BREAKING OFF THE SET SCREW. THE SURGEON THEN REMOVED THE SET SCREW AND BONE SCREW AT L4, AS WELL AS THE ROD. HE THEN PLACED A NEW SCREW AT L3, AND PLACED A ROD FROM L3-L5. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WAS A DELAY OF APPROXIMATELY 45 MINUTES OF ADDITIONAL SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8455005 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page