CD HORIZON® Spinal System 54840007545Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994589293), received between Jan 23, 2017 and Apr 3, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 18, 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.

• InjuryApr 3, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A CONSUMER HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR BROKEN RIGHT SIDE S1 PEDICLE SCREW. PROCEDURE OR TECHNIQUE USED WAS O-ARM NAVIGATED TLIF PROCEDURE. LEVELS IMPLANTED S1. PATIENT HAD A MEDICAL HISTORY OF REGULAR ALCOHOL AND DRUG USE. IT WAS REPORTED THAT THE PATIENT FELL AND HEARD A POP AND FELT PAIN. WENT BACK TO SEE SURGEON WHO WITH IMAGING SAW THE BROKEN SCREW ON THE RIGHT SIDE. REOPERATION WAS PERFORMED TO REPLACE A BROKEN SCREW. AFTER FALL PATIENT SAW THE SURGEON WHO TOOK FILMS AND SAW THE SCREW IN S1 ON THE RIGHT SIDE WAS BROKEN. WHEN SURGEON OPENED THE PATIENT AND REMOVED THE SET SCREWS AND RODS, BOTH S1 SCREWS WERE BROKEN. SURGEON USED 8.0 TREPHINE AND 8.0 CONICAL EXTRACTION BOLT TO REMOVE BOTH BROKEN PIECED THAT REMAINED IN THE S1 BODY AFTER THE BROKEN TOP PORTION WAS REMOVED. PATIENT HAD PAIN AFTERWARDS.

  Patient problems: Pain

  MAUDE report 16661532 ↗
• InjuryApr 3, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A CONSUMER HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR BROKEN RIGHT SIDE S1 PEDICLE SCREW. PROCEDURE OR TECHNIQUE USED WAS O-ARM NAVIGATED TLIF PROCEDURE. LEVELS IMPLANTED S1. PATIENT HAD A MEDICAL HISTORY OF REGULAR ALCOHOL AND DRUG USE. IT WAS REPORTED THAT THE PATIENT FELL AND HEARD A POP AND FELT PAIN. WENT BACK TO SEE SURGEON WHO WITH IMAGING SAW THE BROKEN SCREW ON THE RIGHT SIDE. REOPERATION WAS PERFORMED TO REPLACE A BROKEN SCREW. AFTER FALL PATIENT SAW THE SURGEON WHO TOOK FILMS AND SAW THE SCREW IN S1 ON THE RIGHT SIDE WAS BROKEN. WHEN SURGEON OPENED THE PATIENT AND REMOVED THE SET SCREWS AND RODS, BOTH S1 SCREWS WERE BROKEN. SURGEON USED 8.0 TREPHINE AND 8.0 CONICAL EXTRACTION BOLT TO REMOVE BOTH BROKEN PIECED THAT REMAINED IN THE S1 BODY AFTER THE BROKEN TOP PORTION WAS REMOVED. PATIENT HAD PAIN AFTERWARDS.

  Patient problems: Pain

  MAUDE report 16661515 ↗
• MalfunctionJan 23, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS: ADJACENT LEVEL HERNIATED DISC LEVELS IMPLANTED: L5-S1 IT WAS REPORTED THAT DURING SURGERY, WHEN SURGEON WENT TO REMOVE SET SCREWS AND RODS, ONE OF THE SCREW HEAD BROKE OFF. ADJACENT LEVEL SURGERY WAS PERFORMED WITH ADDITIONAL HARDWARE. PART OF BROKEN PEDICLE SCREW STILL REMAINS IN PATIENT AT S1. NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6269215 ↗

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