CD HORIZON® Spinal System 75445530Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885074133997), received between Apr 11, 2018 and Jul 22, 2020 — classified as 1 injury, 1 malfunction.

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.

• InjuryJul 22, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW FOR A LUMBAR DISCECTOMY AND ARTHRODESIS. IT WAS REPORTED THAT THE SCREW BROKE AND THERE WAS NO FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT'S BODY. THERE WAS A NEED FOR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF FUNCTION BY CHANGING THE SCREW. ADDITIONAL SURGERY WAS PERFORMED TO REMOVE THE BROKEN SCREW AND INSERTED WITH A NEW ONE WITH GREATER DIAMETER AND LENGTH. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. PRE-OP DIAGNOSIS WAS A NARROW CHANNEL DISCECTOMY WAS PERFORMED BETWEEN L5 AND S1 VERTEBRAE, AND FIXATION OF THE PLACE WITH PEDICLE SCREWS, BARS AND BLOCKERS. LEVELS IMPLANTED ARE L5/S1. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO INJURY AS A RESULT OF THIS EVENT. THE PRODUCT WILL BE REPLACED BY A MEDTRONIC PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10306909 ↗
• MalfunctionApr 11, 2018Break; Break

  IT WAS REPORTED THAT THAT ON THE PATIENT UNDERWENT MINI INVASIVE LISTHESIS AT L4-L5 DUE TO SPONDYLOLISTHESIS. POST-OP, THE TULIP PART OF THE SCREW BROKE INSIDE THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. NO ADDITIONAL SURGERY HAS BEEN PERFORMED AS A RESULT OF THE EVENT. THE PATIENT ACHIEVED SOLID FUSION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7422378 ↗

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