CD HORIZON® Spinal System 54410004540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994586766), received between May 9, 2018 and Jul 5, 2018 — 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.

• MalfunctionJul 5, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: THORACIC VERTEBRAL FRACTURE TYPE OF PROCEDURE OR TECHNIQUE USED: OPEN POSTERIOR THORACIC STABILIZATION LEVELS IMPLANTED: T5 IT WAS REPORTED THAT INTRA-OP, IN FINAL TIGHTENING THE SCREW BROKE. THE SCREW WAS REMOVED AND REPLACED WITH NEW ONE. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7662826 ↗
• MalfunctionMay 9, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH THORACIC T4 VERTEBRAL FRACTURE. THE PATIENT UNDERWENT INTERNAL FIXATION OF THORACIC VERTEBRA REDUCTION AND INTERNAL FIXATION. INTRA-OP, THE SURGEON IMPLANTED THE SCREW INTO THE PATIENT'S THORACIC VERTEBRA. IN THE LAST PROCESS OF CLOSING THE LOCK, THE PLUG SCREW HAD NOT BROKEN YET BY ITSELF, BUT THE NAIL TAIL OF THE SCREW HAD BROKEN. THE SURGEON PERFORMED THE OPERATION COMPLETELY ACCORDING TO THE NORMAL MANNER IN THE OPERATION. AFTER THE SCREW WAS BROKEN, THE SURGEON REMOVED THE SCREW AND CONTINUED THE OPERATION WITH THE SAME SPECIFICATION SCREW. NO FRAGMENTS OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7499092 ↗

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