CD Horizon™ ModuLeX™ Spinal System G559300156Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CORTICL CONN G559300156 TOP-SIDE 5.5/6.0 · Class 2 · Implant
All models of CD Horizon ModuLeX Spinal System (34)
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 00763000465599), received between May 7, 2024 and May 7, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2024Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR T12 VERTEBRAL FRACTURE. IT WAS REPORTED THAT THE M5 DOMINO WAS TRIED TO BE PLACED BETWEEN THE L1/2 SCREWS, BUT BECAUSE OF REOPERATION, THE BONE HAD FORMED AND THE DOMINO COULD NOT BE PLACED PROPERLY. WHILE TRYING TO REMOVE THE FULLY FORMED BONE WITH TOOLS SUCH AS A CHISEL OR SHARP SPOON AND PLACE THE M5 DOMINO AGAIN, THE DIRECTION OF THE DOMINO SHIFTED WHILE GRIPPING IT WITH THE HOLDER. AT THAT TIME, THE HOLDER GRIPPING PORTION OF THE DOMINO WAS DEFORMED. A NEW M5 DOMINO WAS USED, AND THE DOMINO WAS SUCCESSFULLY PLACED. THE PROCEDURE PERFORMED WAS T12 PSO, T7-L2 POSTERIOR FIXATION, ROD CONNECTION. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS DAMAGE AT THE GRIP OF THE DOMINO CONNECTOR. ALL DAMAGED PIECES HAVE BEEN RECOVERED FROM THE SURGICAL FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19257475 ↗
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
- 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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