CD Horizon™ ModuLeX™ Spinal System 559200058Recalls & reported problems
Medtronic Sofamor Danek, Inc. · RMAS HEAD PK 559200058 STER 5.5/6.0 2PK · 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 20763000966922), received between Dec 8, 2025 and Dec 8, 2025 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionDec 8, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING THORACOLUMBAR F USION FOR PEDIATRIC SCOLIOSIS. IT WAS REPORTED THAT WHILE PLACING SET SCREWS, SHAVING CAME OFF OF THE TULIP HEADS. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23740731 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.