CD HORIZON® Spinal System 1555501070Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169081284), received between Aug 27, 2018 and Aug 27, 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 (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2018Break; Break

  TYPE OF PROCEDURE: LUMBAR FUSION. LEVELS IMPLANTED: L4-ILIAC. PRE-OPERATIVE DIAGNOSIS: SPONDY. IT WAS REPORTED THAT POST-OPERATIVELY PATIENT HAD BACK PAIN AND LEG PAIN DUE TO BROKEN RODS. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF BROKEN RODS WERE REMAINED IN PATIENT. NO PATIENT COMPLICATIONS OCCURRED DUE TO THIS EVENT.

  Patient problems: Pain

  MAUDE report 7815821 ↗
• InjuryAug 27, 2018Break; Break

  IT WAS REPORTED THAT POST-OPERATIVELY PATIENT HAD BACK PAIN AND LEG PAIN DUE TO BROKEN RODS. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF BROKEN RODS WERE REMAINED IN PATIENT. NO PATIENT COMPLICATIONS OCCURRED DUE TO THIS EVENT.

  Patient problems: Pain

  MAUDE report 7815801 ↗

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.