CD HORIZON® Spinal System 76496545Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885074140148), received between Sep 6, 2022 and Aug 11, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR LUMBAR SPINAL STENOSIS & LUMBAR DISC HERNIATION. PROCEDURE OR TECHNIQUE USED WAS LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT THE TWO SCREWS BROKE INSIDE THE BODY, AND THE PATIENT IS CURRENTLY SUFFERING FROM SEVERE EDEMA OF THE LOWER EXTREMITIES. FRAGMENT LEFT INSIDE THE PATIENT. NO ANY TREATMENT OR ADDITIONAL SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT. PATIENT DID NOT ACHIEVED THE SOLID FUSION. THE PATIENT CURRENTLY DECLARED THAT SHE IS IN CRITICAL CONDITION IN THE ICU WARD, AND THE IMPLANT COULD NOT BE SURGICALLY REMOVED. PATIENT IS CURRENTLY 83 YEARS OLD AND HAS SEVERE LOWER EXTREMITY EDEMA AND IS HOSPITALIZED IN THE ICU. DUE TO THE PATIENT'S PHYSICAL REASONS, THE DOCTOR'S ASSESSMENT AND THE WISHES OF THE PATIENT'S FAMILY MEMBERS, THE SECOND SURGERY MAY NOT BE POSSIBLE.

  Patient problems: Swelling/ Edema

  MAUDE report 17510208 ↗
• InjurySep 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT DURING THE FINAL LOCKING OF THE SPINE FIXATION ASSEMBLY, THE SCREW BECAME DISCONNECTED FROM ITS SCREW HEAD (TULIP SCREW). THE SCREW HAD TO BE REMOVED AND THE ASSEMBLY HAD TO BE EXTENDED TO AN ADDITIONAL FLOOR. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15359328 ↗

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