Skip to content

CD HORIZON® Spinal System 55840014540Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SCREW 55840014540 5.5 CNMAS 4.5X40 CC · Class 2 · Implant

All models of CD HORIZON Spinal System (342)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169076860), received between May 16, 2017 and Nov 15, 2018 — classified as 3 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

Device problems

  • Break2
  • Material Split, Cut or Torn1

Patient problems

  • No Code Available2
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 15, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

    TYPE OF PROCEDURE OR TECHNIQUE USED: PERCUTANEOUS OSTEOSYNTHESIS IT WAS REPORTED THAT POST-OP, THE PATIENT WAS RE-OPERATED BECAUSE THE SCREW OF THE ASSEMBLY WERE TORN OFF. IT WAS OBSERVED THAT THE 4.5 DIAMETER SCREW WAS NO LONGER POLY- AXIAL BUT LOCKED WITH ANGULATION, HENCE THEY HAD BEEN TORN OFF.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8072822 ↗
  • InjuryMay 16, 2017Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2014, PATIENT UNDERWENT FRACTURE BRACING SURGERY DUE TO L1 BURST FRACTURE AT LEVELS T12- L2. POST-OP, SCREWS BROKE. PATIENT DID NOT ACHIEVE FUSION AS BROKEN SCREWS LEAD TO MOBILE SITE. NO FRAGMENTS REMAINED INSIDE THE PATIENT. PATIENT UNDERWENT REVISION SURGERY FOR THE REMOVAL OF BROKEN SCREWS. SCREWS EX PLANTED COMPLETELY. RIGHT IN THE MIDDLE OF THE SCREW THREAD BROKE.

    Patient problems: No Code Available

    MAUDE report 6568558 ↗
  • InjuryMay 16, 2017Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2014, PATIENT UNDERWENT FRACTURE BRACING SURGERY DUE TO L1 BURST FRACTURE AT LEVELS T12- L2. POST-OP, SCREWS BROKE. PATIENT DID NOT ACHIEVE FUSION AS BROKEN SCREWS LEAD TO MOBILE SITE. NO FRAGMENTS REMAINED INSIDE THE PATIENT. PATIENT UNDERWENT REVISION SURGERY FOR THE REMOVAL OF BROKEN SCREWS. SCREWS EX PLANTED COMPLETELY. RIGHT IN THE MIDDLE OF THE SCREW THREAD BROKE.

    Patient problems: No Code Available

    MAUDE report 6568557 ↗

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.

Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices

All Orthosis, spinal pedicle fixation, for degenerative disc disease devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page