CD HORIZON® Spinal System 75447545Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074134215), received between Apr 10, 2017 and Apr 10, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K042025); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT POSTERIOR SPINAL FUSION SURGERY DUE TO PRE-OP DIAGNOSIS AS L5-S1 "SPONDY". POST-OP, THE TULIP HEAD BROKE OFF OF THE SCREW SHAFT. DUE TO WHICH PATIENT HAD SACRAL FRACTURE AND HARDWARE REVISION WAS PERFORMED ON (B)(6) 2017. IN REVISION SURGERY, L2-ILIUM FIXATION WAS PERFORMED AND BROKEN SCREW WAS REMOVED. NO FRAGMENTS OF THE BROKEN SCREW REMAINED INSIDE THE PATIENT.

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 6474732 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042025. One submission often covers many models, so check the product and lot details in each record.

• Z-0464-2012 · Nov 30, 2011 · Terminated
  CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X0809439, Rx only, Medtronic Sofamor Danek USA, 1800
• Z-0465-2012 · Nov 30, 2011 · Terminated
  CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Py
• Z-2875-2011 · Jun 28, 2011 · Terminated
  CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization a
• Z-2878-2011 · Jun 28, 2011 · Terminated
  ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilizat