CD HORIZON® Spinal System 75445545Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885074134024), received between Mar 23, 2018 and Mar 7, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING TL OPEN PRO CEDURES. IT WAS REPORTED THAT AFTER THE SURGEON IMPLANTED THE SCREWS IN THE MONTH OF DECEMBER, WHICH WERE NOW BROKEN. REVISION SURGERY WAS PERFORMED TO EXPLANT THE IMPLANT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGAR DING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21544736 ↗
• InjuryJan 31, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR PAIN. IT WAS REPORTED THAT TWO SCREWS BROKE. PART OF ONE OF THE SCREW THREAD REMAINS IN VERTEBRA PATIENT. THE SCREWS WERE EXPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270403 ↗
• InjuryJan 22, 2020Break; Break

  POST-OP, THE IMPLANTED SCREW BROKE AND PATIENT SUFFERED FROM PAIN IN THE LUMBAR REGION AND EXPERIENCE LONG-TERM NUMBNESS AND TINGLING FEELING IN THE LEGS. FOR THE EXPLANTATION OF BROKEN SCREW THE PATIENT UNDERWENT REVISION SURGERY. THE EVENT PROCEEDED WITHOUT COMPLICATIONS. THE OPERATOR WAS HAPPY WITH THE RESULT.

  Patient problems: Numbness; Pain; Tingling

  MAUDE report 9615517 ↗
• MalfunctionJun 26, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISC DISEASE AND UNDERWENT POSTERIOR STABILIZATION SURGERY AT L4-L5-S1 LEVELS. POST-OPERATIVELY, THE SCREW WAS FOUND BROKEN ON THE RIGHT SIDE OF S1. THE PATIENT HAS ACHIEVED SOLID FUSION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7636641 ↗
• InjuryMar 23, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MINIMAL ACCESS SURGICAL TECHNOLOGY- POSTERIOR LUMBAR INTERBODY FUSION (MAST- PLIF) AT L4-5 DUE TO LYTIC LISTHESIS AT THAT LEVEL. POST-OP (DURING DEVICE MAINTENANCE), THE SCREW WAS FOUND BROKEN. REPORTEDLY, THE PATIENT WAS IN TREMENDOUS BACK PAIN. HENCE, A REVISION SURGERY WAS PERFORMED IN WHICH THE BROKEN SCREW WAS PARTIALLY EXPLANTED, THE SCREW SHAFT WAS LEFT INSIDE THE PATIENT.

  Patient problems: Pain

  MAUDE report 7365119 ↗

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-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-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-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
• 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