CD HORIZON® Spinal System 55840004550Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169004818), received between Jun 10, 2020 and Jun 10, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Erosion” (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.

• InjuryJun 10, 2020Material Erosion; Naturally Worn; Material Erosion; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ADULT DEFORMITY WITH BOTH CORONAL AND SAGGITAL PLANE IMBALANCE, MULTILEVEL SPINAL STENOSIS AND L5 RADICULOPATHY WITH WEAKNESS AND NEUROGENIC CLAUDICATION. HE UNDERWENT T11-PELVIS FUSION. ON AN UNKNOWN DATE, POST-OP, THE SADDLE OF THE REPORTED SCREW (THAT WAS IMPLANTED AT RIGHT T12) WAS WORN HEAVILY. TWO SET SCREWS WERE ALSO FOUND LOOSENED AND DISLODGED. ADDITIONALLY, THERE WAS METALLOSIS AROUND THE TREATED SITE AND PSEUDOARTHROSIS AT T11-T12 WAS ALSO REPORTED. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE ALLEGED SCREW AND OTHER HARDWARE WERE COMPLETELY EXPLANTED AND WERE REPLACED WITH NEW ONES. EXTENSION OF FUSION FROM T4 TO T11 WAS ALSO PERFORMED AS A RESULT OF PROXIMAL JUNCTIONAL KYPHOSIS AND JUNCTIONAL FAILURE OF T11.

  Patient problems: Failure of Implant

  MAUDE report 10140741 ↗

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.