CD HORIZON® Spinal System 54840016545Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994592392), received between Jan 9, 2018 and Feb 9, 2023 — classified as 2 injuries.

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 16, 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.

• InjuryFeb 9, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SCREW USED IN MIS TRANSFORAMINAL LUMBAR INTERBODY FUSION TLIF. IT WAS REPORTED THAT SCREW BROKE AND FRAGMENTS OF IMPLANT REMAINING IN THE PATIENT. THE SHANK OF THE SCREW REMAINS IMPLANTED. NO OTHER ADVERSE EVENT OCCURRED TO PATIENT. THE PATIENT¿S MEDICAL HISTORY INCLUDED STENOSIS. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED. ADDITIONAL INFORMATION RECEIVED THAT THE SCREW WAS ALREADY BROKEN BEFORE EXPLANATION SURGERY. PRE-OP DIAGNOSIS FOR THE PATIENT IN THIS EVENT WAS SOINSL STENOSIS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16334966 ↗
• InjuryJan 9, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION. REPORTEDLY POST-OP, S1 SCREW BROKE BELOW TULIP. THE PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF HARDWARE AND RE-INSTRUMENTATION. THE SURGEON PERFORMED AN ANTERIOR LUMBAR INTERBODY FUSION AND A REVISION POSTERIOR FUSION. NO FRAGMENTS OF THE DEVICES REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT ACHIEVE SOLID FUSION. THE PATIENT TESTED POSITIVE FOR GRAM NEGATIVE BACILLI.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 7174409 ↗

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