CD HORIZON® Spinal System 75495535Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885074134437), received between Jun 28, 2019 and Feb 8, 2021 — 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 18, 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.

• InjuryFeb 8, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF DEGENERATIVE DISEASE. IT WAS REPORTED THAT POST-OP, SCREW BROKE. THERE WERE NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. SCREW IS EXPLANTED. FURTHER, THERE WERE NO COMPLICATIONS ASSOCIATED WITH THE EVENT. BROKEN PEDICLE SCREW PRODUCT HAS BEEN REMOVED FROM THE PATIENT, AND THE PRODUCT HAS BEEN HANDLED BY OUR DISTRIBUTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11292598 ↗
• InjuryJun 28, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEGENERATIVE DISEASE AT LUMBAR REGION; AND UNDERWENT DECOMPRESSION WITH POSTERIOR LUMBAR INTERBODY FUSION ON (B)(6) 2018. ON AN UNKNOWN DATE, POST-OP, THE PEDICLE SCREW BROKE. HENCE, ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE BROKEN SCREW WAS COMPLETELY EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8742971 ↗

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