CD HORIZON® Spinal System 54840008580Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994590466), received between Mar 17, 2025 and Mar 17, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K091974); they may or may not involve this specific model.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. THE PRE-OP DIAGNOSIS OF PATIENT WAS DEGEN SPINE LUMBAR. IT WAS REPORTED THAT, THE HEAD OF TULIP WAS STRIPPED. PROCEDURE OR TECHNIQUE PLANNED WAS POSTERIOR LUMBAR FUSION. THERE WAS A SURGICAL DELAY OF 30 MINUTES REPORTED IN ORDER TO REMOVE SCREW AND REPLACE. NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21616635 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091974. One submission often covers many models, so check the product and lot details in each record.

• Z-2876-2011 · Jun 28, 2011 · Terminated
  CD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilizatio