CD HORIZON® Spinal System 75447535Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074134192), received between Dec 16, 2021 and Dec 16, 2021 — 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.

• InjuryDec 16, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A DISTRIBUTOR REGARDING MULTI AXIAL SCREWS IMPLANTED IN A PATIENT DURING SPINAL FIXATION AT L5-S1 FOR MATERIAL REMOVAL. IT WAS REPORTED THAT SCREWS BROKE. IMAGING STUDIES WERE PERFORMED IDENTIFYING BILATERAL SACRAL SCREW FRACTURE. THE PATIENT HAD EPISODES OF LOWER LIMB PAIN, BILATERAL PARESTHESIA, DECREASED STRENGTH, AND DIFFICULTY WALKING. A SURGERY FOR MATERIAL REMOVAL AND REPLACEMENT OF BOTH SACRAL SCREWS WAS PERFORMED. THE DATE OF IMPLANT WAS (B)(6) 2021 AND DATE OF EXPLANT WAS (B)(6) 2021. THE PATIENT'S MEDICAL HISTORY INCLUDES APPROXIMATELY 1 YEAR OF HAVING SUFFERED A FALL FROM STAIRS AND TRAUMATIZING THE LUMBAR REGION. SO AT THE TIME OF OCCLUSION, A DIAGNOSIS OF A L1 AND L4-L5 FRACTURE WAS MADE FOR WHICH SHE WAS OPERATED ON. THE PATIENT HEARD A CLICKING SOUND AFTER WHICH HE PRESENTED EPISODES OF LOWER LIMB PAIN, BILATERAL PARESTHESIA, DECREASED STRENGTH AND DIFFICULTY WALKING. PATIENT DENIES FALL AND TRAUMA PRIOR TO EPISODES OF PAIN. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Ambulation or Postural Difficulties; Muscle Weakness/Atrophy; Pain; Paresthesia

  MAUDE report 13017093 ↗

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