CD HORIZON® Spinal System 86946540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885074171067), received between Nov 15, 2016 and Aug 28, 2020 — classified as 1 injury, 1 malfunction.

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

• InjuryAug 28, 2020Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE ROD HAS SLIPPED. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 2020-AUG-14: AFTER THE UNIVERSAL SCREW PLACEMENT, THE ROD AND THE SCREW PLUG WERE PUT ON, AND THERE APPEARED SLIPPED BETWEEN THE SCREW PLUG AND THE SCREW WALL, LEADING TO UNABLE TO FIX AFTER THE PLUG WAS BROKEN, AND THE ROD FELL OFF FROM THE SCREW SLOT AFTER THE SURGERY. THE SECOND SURGERY WAS PERFORMED, THE SLIPPED SCREW AND SCREW CAP WERE REMOVED AND THE SCREW WAS RE-IMPLANTED. THIS IS A POST-OP EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10464050 ↗
• MalfunctionNov 15, 2016Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE DUE TO LUMBAR INTER-VERTEBRAL DISC DEGENERATION. DURING PROCEDURE, THE DEVICE WAS FOUND SLIPPED AND COULD NOT BE USED ANYMORE. THE SURGEON HAD TO REPLACE IT WITH NEW ONE TO COMPLETE THE SURGERY. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6101333 ↗

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-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