CD HORIZON® Spinal System 54840005535Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994589767), received between Mar 28, 2023 and Mar 28, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 28, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING SCREWS USED IN OPEN TLIF CORTICAL TRAJECTORY FOR STENOTIC ADJACENT DISEASE. LEVELS IMPLANTED: L4-L5 IT WAS REPORTED THAT THE SCREWS WERE REALISED TO BE BROKEN BEFORE THE REVISION SURGERY. BROKEN THREADS AT L5 STILL IN PATIENT. ORIGINAL SURGERY WAS A L4-L5 TLIF. THE PATIENT HAD DEVELOPED STENOTIC ADJACENT LEVEL DISEASE AND A L3-L4 TLIF WAS PERFORMED. EXISTING CONSTRUCT AT L4-L5 WAS REMOVED AND INSTRUMENTED L3-L4 WITH NEW SOLERA 5.5/6.0 SYSTEM AND LEFT THE BROKEN THREADS AT L5. THE PRE-OP PLAN WAS TO PERFORM L3-L4 TLIF WITH REMOVAL OF OLD HARDWARE AT L4-L5, PERFORMED TLIF AT L4-L5 AS PLANNED NO COMPLICATIONS POST OP OR DURING USE. NO PATIENT SYMPTOMS WERE REPORTED. NO ADDITIONAL SURGERY WAS PERFORMED. REVISION SURGERY WAS PERFORMED FOR THE STENOTIC ADJACENT DISEASE AND NOT BECAUSE OF THE BROKEN SCREWS. MEDICAL HISTORY: PRIOR LAMENECTOMIES NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16626406 ↗

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