CD HORIZON® Spinal System 1555501090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169081321), received between Jun 14, 2022 and Jun 14, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 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 14, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM LEGAL VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SPINAL STERILE IMPLANTABLE HARDWARE FOR AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANT FROM A PRIOR SURGERY WHICH WAS IMPLANTED ON (B)(6) 2019 WAS BROKEN OFF LEAVING A SCREW IMBEDDED IN THE SPINE & AN UNSTABLE ROD WHICH INCREASED THE PRESSURE ON THE TWO REMAINING SCREWS. THE DAMAGED & BROKEN HARDWARE WAS THE PROXIMATE CAUSED THE SUBSTANTIAL PAIN TO THE PATIENT. ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2020 FOR REPLACING THE BROKEN IMPLANTED HARDWARE TO RE-STABILIZE THE PATIENT SPINE. PATIENT VISITED ON (B)(6) 2020. DIAGNOSIS: LOW BACK PAIN SUBJECTIVE: PATIENT SYMPTOMS AGGRAVATE WITH THE FOLLOWING MOVEMENT/POSITION/TASK: RAISING UE¿S OH, PROLONGED SITTING/ WALKING. PATIENT SYMPTOMS IMPROVE WITH THE FOLLOWING MOVEMENT/POSITION/TASK/ RELATIVE REST TREATMENT TO FOCUS ON PATIENT¿S CHIEF COMPLAINT: DIFFICULTY WALKING, DIFFICULTY WITH PROLONGED SITTING, DIFFICULTY WITH PROLONGED STANDING, PAIN WHICH INTERFERES WITH ADL¿S, STIFFNESS & WEAKNESS. ASSESSMENT: PATIENT PRESENTS WITH SIGNS AND SYMPTOMS CONSISTENT S/P I-SP FUSION ON (B)(6) 2019. PT. PRESENTS WITH WEAK HIPS/CORE/G

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 14683962 ↗

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.