CD HORIZON® Spinal System 54840008545Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994590534), received between Mar 23, 2018 and Jul 13, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K091974); 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.

• InjuryJul 13, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED IN NAVIGATED POSTERIOR LUMBAR FUSION THERAPY FOR REVISION FOR BROKEN SCREW AND EXTENSION OF CONSTRUCT. LEVELS IMPLANTED: L4-S2 IT WAS REPORTED THAT THE PATIENT HAD TWO BROKEN SCREWS THAT WERE REVISED ON (B)(6) 2023. THE DOCTOR REVISED THE PREVIOUS CONSTRUCT AND WAS ABLE TO REMOVE BOTH SCREWS FROM S1, HE REPLACED THEM WITH 8,5MM DIAMETER SCREWS AND NEW RODS. ALSO AT THAT TIME, HE USED INFUSE IN THE LATERAL GUTTERS. THAT SAME PATIENT WENT BACK TO THE DOCTOR WITH PAIN IN HIS BACK AND THE BROKEN SCREW WAS DISCOVERED. SO TODAY, HE REMOVED ALL SCREWS (L4, L5 AND S1) AND REPLACED THEM WITH NEW SCREWS. THE SCREW THAT WAS BROKEN WAS IN THE S1 RIGHT SIDE. THE BROKEN SCREW WAS NOT REMOVED BUT A SECOND SCREW (B)(6) WAS NAVIGATED INTO PLACE ALONGSIDE THE BROKEN PIECE IN S1 RIGHT SIDE. THE DOCTOR ALSO ADDED TWO S2 SCREWS THAT WENT THROUGH S2 AND INTO THE ILIUM. THOSE S2 SCREWS WERE 8.5X80MM. THERE WAS AN ATTEMPT TO R EMOVE THE BROKEN PIECE, BUT THERE WAS NOT A CONNICAL EXTRACTION BOLT LARGE ENOUGH TO GRAB THE 8.5MM DIAMETER SCREW FRAGMENT, SO THE DOCTOR DECIDED THAT HE WOULD NAVIGATE A

  Patient problems: Pain

  MAUDE report 17315088 ↗
• InjuryMar 23, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2017: PATIENT UNDERWENT LUMBAR HARDWARE REVISION WITH REMOVAL OF THE S1 SCREWS AND ROD. DURING THE SURGERY, TWO NEW SCREWS WERE IMPLANTED AT S1. POST-OP, ON (B)(6) 2017, PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LOW BACK PAIN. PATIENT WAS POST-OPERATIVELY DIAGNOSED WITH BACK PAIN AND WOUND INFECTION. PATIENT UNDERWENT HARDWARE REMOVAL OF PEDICLE SCREW OF S1 AND RODS AND IRRIGATION AND CULTURE OF WOUND INFECTION AND IRRIGATION OF GROSS PUS. DURING THE REMOVAL SURGERY, BOTH THE SCREWS WERE FOUND LOOSENED AT S1.

  Patient problems: Pain; Post Operative Wound Infection

  MAUDE report 7364861 ↗
• InjuryMar 23, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2017: PATIENT UNDERWENT LUMBAR HARDWARE REVISION WITH REMOVAL OF THE S1 SCREWS AND ROD. DURING THE SURGERY, TWO NEW SCREWS WERE IMPLANTED AT S1. POST-OP, ON (B)(6) 2017, PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LOW BACK PAIN. PATIENT WAS POST-OPERATIVELY DIAGNOSED WITH BACK PAIN AND WOUND INFECTION. PATIENT UNDERWENT HARDWARE REMOVAL OF PEDICLE SCREW OF S1 AND RODS AND IRRIGATION AND CULTURE OF WOUND INFECTION AND IRRIGATION OF GROSS PUS. DURING THE REMOVAL SURGERY, BOTH THE SCREWS WERE FOUND LOOSENED AT S1.

  Patient problems: Pain; Post Operative Wound Infection

  MAUDE report 7364860 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091974. One submission often covers many models, so check the product and lot details in each record.

• Z-2876-2011 · Jun 28, 2011 · Terminated
  CD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilizatio