CD HORIZON® Spinal System 1555501100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169081345), received between Nov 2, 2020 and Nov 2, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

1 other recall cover devices cleared under the same FDA submission (K113174); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 2, 2020Biocompatibility; Biocompatibility

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION IN NEED OF L1-L5 POSTERIOR APPROACH PATIENT PRONE PROCEDURE USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT HAD A REACTION POTENTIALLY ALLERGIC REACTION TO THE COBALT CHROME (CHROMALOY) CONSTRUCT OF SOLERA 5.5/6.0. THERE WAS METAL DEBRIS IS SOFT TISSUE AND MUSCLE THAT WAS VISIBLE AFTER INCISION. REVISION SURGERY WAS PERFORMED AND REPLACED ALL SCREWS WITH LEGACY TITANIUM AND EXTENDED THE CONSTRUCT. A PREVIOUS METAL ALLERGY WAS NOT DOCUMENTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Foreign Body Reaction

  MAUDE report 10768674 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113174. One submission often covers many models, so check the product and lot details in each record.

• Z-2603-2018 · Jul 9, 2018 · Terminated
  Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.