CD HORIZON® Spinal System 54840005540Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994589750), received between Jul 11, 2017 and Jul 11, 2017 — 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.

• InjuryJul 11, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) WITH SCREWS AND CAGE IMPLANTATION AT LEVEL L5-S1. POST-OP, THE SCREW IMPLANTED AT THE RIGHT S1 BROKE. A TLIF REVISION WAS PERFORMED TO REPLACE THE SPLIT SCREW. THE TIP OF THE SCREW STILL REMAINED IN THE PATIENT. NO PATIENT COMPLICATION HAVE BEEN REPORTED AFTER THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 6700094 ↗

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