CD HORIZON® Spinal System 55410007545Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169074194), received between Feb 18, 2019 and Feb 18, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PATIENT UNDERWENT DEFORMATION CORRECTION SURGERY AT TH4-L5. INTRA-OP, THE SET SCREW OVERTURNED, WHICH DESTROYED THE FIXED-ANGLE SCREW. THE DAMAGED SCREW WAS THEN EXPLANTED AND REPLACED WITH A MULTI-AXIAL SCREW. THE SET SCREW OVERTURNED BECAUSE THE SURGEON DID NOT USE A COUNTER-TORQUE INSTRUMENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8346826 ↗

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.