CD HORIZON® Spinal System 54410006545Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994585738), received between Jun 19, 2018 and Jan 1, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 1, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING POSTERIOR O PEN REDUCTION AND SCREW-ROD SYSTEM INTERNAL FIXATION FOR LUMBAR 3 VERTEBRAL COMPRESSION FRACTURE. IT WAS REPORTED THAT THE SCREW TIP BROKE DURING IMPLANTATION. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21051279 ↗
• MalfunctionJun 19, 2018Break; Break

  TYPE OF PROCEDURE: POSTERIOR FUSION. PRODUCT STATUS: EXPLANTED-COMPLETE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE FAS SCREW WAS BROKEN WHILE FINAL TIGHTENING. THE BROKEN SCREW WAS REMOVED AND REPLACED WITH ANOTHER AND PROCEDURE WAS COMPLETED. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THE REPORTED EVENT. UPDATE RECEIVED ON 18 JUN 2018: SCREW HEAD WAS BROKEN. BROKEN PART OF SCREW WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7612644 ↗

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