CD HORIZON® Spinal System 54840006555Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994579591), received between Mar 23, 2018 and Mar 2, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR FUSION SURGERY AT L3-L5 DUE TO SOME UNKNOWN REASONS. POST-OP, IT WAS OBSERVED THAT THE IMPLANTED SCREW AT L5 WAS BROKEN. THE PATIENT WAS GETTING HIS TEETH CLEANED AT THE DENTIST WHEN HE FELT A POPPING SENSATION AND THEN EXPERIENCED PAIN AFTERWARDS. THERE WAS PAIN IN BACK OF THE PATIENT. ADDITIONAL SURGERY WAS ALSO PERFORMED AS A RESULT OF THE EVENT. DOCTOR REMOVED THE BROKEN SCREW. IT CAME OUT IN 2 PIECES. DOCTOR REPLACED THAT BROKEN SCREW WITH A 10.5X55MM SCREW.

  Patient problems: Pain

  MAUDE report 9773450 ↗
• InjuryMar 23, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2016: PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR STENOSIS WITH FACET ARTHROPATHY AT L4-L5 AND L5-S1. PATIENT UNDERWENT DECOMPRESSIVE LUMBAR LAMINECTOMY, TRANSLUMBAR INTERBODY FUSION AT L4-L5 AND L5-S1. INTRAOPERATIVE EMG AND C-ARM X-RAY WAS ALSO PERFORMED. POST-OP, DURING REVISION SURGERY, PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LOW BACK PAIN. PATIENT WAS POST-OPERATIVELY DIAGNOSED WITH BACK PAIN AND WOUND INFECTION. PATIENT UNDERWENT HARDWARE REMOVAL OF PEDICLE SCREW AND IRRIGATION AND CULTURE OF WOUND INFECTION AND IRRIGATION OF GROSS PUS. DURING THE REMOVAL SURGERY, SCREW WAS FOUND LOOSE AT L4.

  Patient problems: Pain; Post Operative Wound Infection

  MAUDE report 7364868 ↗
• InjuryMar 23, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2016: PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR STENOSIS WITH FACET ARTHROPATHY AT L4-L5 AND L5-S1. PATIENT UNDERWENT DECOMPRESSIVE LUMBAR LAMINECTOMY, TRANSLUMBAR INTERBODY FUSION AT L4-L5 AND L5-S1. INTRAOPERATIVE EMG AND C-ARM X-RAY WAS ALSO PERFORMED. POST-OP, DURING REVISION SURGERY, PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LOW BACK PAIN. PATIENT WAS POST-OPERATIVELY DIAGNOSED WITH BACK PAIN AND WOUND INFECTION. PATIENT UNDERWENT HARDWARE REMOVAL OF PEDICLE SCREW AND IRRIGATION AND CULTURE OF WOUND INFECTION AND IRRIGATION OF GROSS PUS. DURING THE REMOVAL SURGERY, SCREW WAS FOUND LOOSE AT L4.

  Patient problems: Pain; Post Operative Wound Infection

  MAUDE report 7364865 ↗

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