CD HORIZON® Spinal System 55890007550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169057258), received between Mar 16, 2020 and Jul 17, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjuryJul 17, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A FRACTURE WITH SEQUELA FOR SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE ROD WAS BROKEN AND SCREW WAS REMOVED. REINTERVENTION WAS DONE FOR OSTEOTOMY WITH SEQUELA FOR FRACTURE. THE DEVICE WAS REPLACED AND WILL BE RETURNED. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WERE NO PATIENT SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 10288964 ↗
• MalfunctionMar 16, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH POSTERIOR JUNCTIONAL KYPHOSIS; AND UNDERWENT EXTENSION OF CORRECTION FROM T9 TO ILIAC. AFTER PUTTING IN ALL NEW SCREWS, WHEN THE SURGEON WAS PLACING A NEW ROD, HE ENCOUNTERED SOME PROBLEM PUTTING THE ROD INTO ONE OF THE OLD SCREW¿S TULIP HEAD. THE TULIP HEAD WAS FOUND TILTED TO ONE SIDE AND WAS UNABLE TO MOVE AS COMPARED TO THE REST OF THE OLD SCREWS. HENCE, THE ALLEGED SCREW WAS REMOVED; AND WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9834446 ↗

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.