CD HORIZON® Spinal System 75447540Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885074134208), received between Apr 22, 2019 and Dec 12, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789928 ↗
• InjuryOct 26, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A SCREW IN A NORMAL SPINAL DEGENERATIVE FIXATION AT 4 LEVELS. IT WAS REPORTED THAT THE SCREW BROKE. THE PATIENT EXPERIENCED PAIN. THE EVENT LED TO/ EXTENDED PATIENT HOSPITALIZATION FOR REINTERVENTION TO REMOVE THE BROKEN SCREW. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Pain

  MAUDE report 15672064 ↗
• InjuryMar 15, 2021Break; Use of Device Problem; Break; Use of Device Problem

  INFORMATION WAS RECEIVED FROM DISTRIBUTOR VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF SPONDYLOLISTHESIS AT L5-S1 INVOLVED IN SPINAL THERAPY. LEVELS IMPLANTED- L4 - S1 IT WAS REPORTED THAT DURING NORMAL USE, SPINAL SCREW BROKE. THEY MADE AN INCISION IN THE MIDLINE, DISINSERTED THE MUSCLE PLANE, AND EXPOSED THE IMPLANTED MATERIAL. THEY PROCEEDED TO REMOVE THE CROSSLINK, THEN REMOVE THE BREAK OFFS, THEN THE BARS AND REMOVE THE CROWNS OF THE BROKEN SCREWS FROM S1, THEN REMOVE THE 2 INTEGRAL SCREWS FROM L4 AND TRIED TO EXPLANT THE THREADED PORTION OF THE S1 SCREWS THAT WERE STILL IMPLANTED BUT DUE TO THE LEVEL OF FUSION AND NOT HAVING A SUITABLE SURFACE FOR HOLDING, THE DOCTOR LEFT THE MATERIAL IN S1. PRODUCT WAS NOT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. PATIENT SYMPTOMS OR COMPLICATIONS WAS REPORTED AS A RESULT OF THIS EVENT. PAIN WAS REPORTED. THE SCREW THREAD WAS IMPLANTED ON S1. NO ADDITIONAL SURGERY/TREATMENT PERFORMED AS A RESULT OF THIS EVENT. PRODUCT WAS EXPLANTED PARTIALLY. PATIENT IS ALIVE AND NO INJURY. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT EVENT WAS REVISION SURGERY TO EXPLANT BROKEN SCREW. PATIENT WAS ASYMPT

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 11479193 ↗
• InjuryApr 22, 2019Material Integrity Problem; Material Integrity Problem

  TRANSPEDICULAR SCREW LEVELS IMPLANTED: L4-L5 IT WAS REPORTED THAT, POST-OP, THE IMPLANTED SCREW WAS FATIGUED. THE PHYSICIAN TRIED TO REMOVE STEM FROM THE SCREW BUT IT WAS NOT ALLOWED. THE BODY OF THE SCREW REMAINED IN THE PATIENT. "ALIF SOUVERING" WAS PERFORMED AS A RESULT OF ALLEGED EVENT. PATIENT DID NOT ACHIEVE SOLID FUSION. NO OTHER INFO WAS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 8535108 ↗

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