CD HORIZON® Spinal System 75496545Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074135205), received between Mar 9, 2018 and May 16, 2023 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGOING TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF) FOR SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE SCREW BROKE DURING IMPLANTATION. NO FRAGMENT OF THE IMPLANT REMAINS INSIDE THE PATIENT. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16937654 ↗
• MalfunctionApr 23, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR OPEN REDUCTION BONE GRAFT FUSION AND INTERNAL FIXATION DUE TO L4 VERTEBRAL SPONDYLOLISTHESIS. INTRA-OP, BONE SCREW CRITICAL WALL BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8539204 ↗
• MalfunctionMar 9, 2018Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: LUMBAR DEGENERATIVE IT WAS REPORTED THAT INTRA-OP, THE SET SCREW SLIPPED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7327781 ↗

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