CD HORIZON® Spinal System 54840015535Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994592811), received between Jan 10, 2018 and Jan 10, 2018 — 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. How this data works · Data updated Oct 13, 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.

• InjuryJan 10, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT MIDLINE LUMBAR INTERBODY FUSION (MIDLIF) SURGERY. POST-OP, SCREW WAS FOUND BROKEN. A REVISION SURGERY WAS PERFORMED TO REMOVE THE SCREW. THE END OF BROKEN SCREW COULD NOT BE EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7177655 ↗
• InjuryJan 10, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT MIDLINE LUMBAR INTERBODY FUSION (MIDLIF) SURGERY. POST-OP, SCREW WAS FOUND BROKEN. A REVISION SURGERY WAS PERFORMED TO REMOVE THE SCREW. THE END OF BROKEN SCREW COULD NOT BE EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7177654 ↗

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