CD HORIZON® Spinal System 54840005545Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994589743), received between Dec 16, 2020 and Dec 16, 2020 — classified as 1 injury.

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 18, 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.

• InjuryDec 16, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF BACK PAIN WITH RADICULOPATHY AND L4-L5 SPONDYLOLISTHESIS IN NEED OF L4-L5 STABILIZATION AND LAMINECTOMY USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW HAS BROKEN THAT WAS IMPLANTED ON (B)(6) 2019 AND PATIENT INSTABILITY WITH BACK PAIN. THE BROKEN SCREW WAS REMOVED AND IMPLANTED A BIGGER ONE. THERE WAS NO FUSION AFTER ONE YEAR. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THE PATIENT ISSUE HAS BEEN RESOLVED AFTER SECOND SURGERY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 11017295 ↗

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