CD Horizon™ ModuLeX™ Spinal System 559200102Recalls & reported problems
Medtronic Sofamor Danek, Inc. · RDRMAS 559200102 HEAD W/2 SET SCREWS · Class 2 · Implant
- 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 20763000710532), received between May 12, 2026 and May 12, 2026 — 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. How this data works · Data updated Oct 13, 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 12, 2026Material Deformation
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR PREVIOUS ADULT DEFORMITY FUSION, T3-SACRUM. IT WAS REPORTED THAT UPON REDUCING THE SET SCREW INTO THE SCREW HEAD SURGEON SAW METAL SHAVINGS FROM THE RDRMAS SCREW AND SET SCREW FROM SEVERAL OF THEM. THERE WERE NO ISSUES OBSERVED FOR THE FINAL TIGHTENING OF THE SYSTEM. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THIS WAS A REVISION OF AN ADULT DEFORMITY SURGERY FROM C2-SACRUM WHERE MODULEX WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25146349 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.