CD HORIZON® Spinal System 7577545Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885074032047), received between Oct 9, 2018 and Mar 30, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT LUMBAR FUSION FOR DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR A FOLLOW-UP VISIT SEVEN MONTHS POST-OP, THE PHYSICIAN DISCOVERED THAT THE HEAD AND SHANK OF OUR SCREW HAD SEPARATED/DISLODGED. PATIENT WAS STILL IN BACK PAIN. THE DOCTOR'S CUR RENT EVALUATION IS TO KEEP THE PATIENT UNDER OBSERVATION. THERE IS NO NEED TO SCHEDULE A SECOND SURGERY YET. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Back pain

  MAUDE report 24713437 ↗
• MalfunctionNov 28, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT THE SCREW HEAD WAS BROKEN FROM THE SHAFT. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23670342 ↗
• InjuryJun 16, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A SCREW AND ROD IMPLANTED IN A PATIENT. PROCEDURE PERFORMED WAS MIS TLIF WITH PERCUTANEOUS SCREW FIXATION. PRE-OP DIAGNOSIS WAS LUMBAR STENOSIS WITH SPONDYLOLISTHESIS. IT WAS REPORTED THAT POST-OPERATIVELY, SURGEON FOUND THE SCREW HEAD WAS SEPARATED WITH SCREW DURING THE CASE FOLLOW UP. THE C RING IN THE BOTTOM OF THE SCREW HEAD WAS BROKE. THERE WAS NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. THE ROD WAS INTACT. SURGEON REMOVED THE LOOSENING SCREW AND ROD AND IMPLANTED NEW SCREW AND ROD. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12010369 ↗
• InjuryMay 20, 2020Break; Break

  IT WAS REPORTED THAT ABOUT 3 YEARS BACK, THE PATIENT UNDERWENT MINIMAL INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF) AT L5-S1. CAGE (FROM VELOFIX VENDOR), SCREWS AND RODS WERE IMPLANTED IN THE PATIENT DURING THIS SURGERY. ON AN UNKNOWN DATE, A YEAR AND 4 MONTHS POST-OP, THE PATIENT PRESENTED WITH NON-UNION. REPORTEDLY, THE PATIENT STARTED TO HEAR NOISES (CLICKS) IN HIS BACK AND THE PATIENT HAD A LOT OF PAIN IN HIS BACK. REPORTEDLY, THERE WAS FUSION AT ONLY ONE SIDE; AND LIKELY, THE CAGE WAS SMALL DUE TO WHICH THERE WAS A LITTLE GAP BETWEEN VERTEBRAE. HENCE, THE PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) TO REPLACE THE CAGE IMPLANTED IN THE PREVIOUS SURGERY. IN THIS SURGERY, THE CAGE WAS REPLACED WITH A NEWER AND A BIGGER ONE, IN WHICH MORE AMOUNT OF BONE MATERIAL WAS PLACED. THE PATIENT STARTED TO FEEL BETTER AFTER ALIF, BUT THERE WAS STILL PAIN IN THE PATIENT'S BACK. THE PATIENT STILL HEARD CLICK NOISES IN HIS BACK. SO, A YEAR LATER, ANOTHER SURGERY WAS PERFORMED, IN WHICH REMOVAL OF SCREWS AND RODS WAS PERFORMED. IT WAS FOUND THAT THE AREA WHERE THE PATIENT WAS EXPERIENCING PAIN, WAS THE SAME PLACE AT WHICH THE SCREW BROKE. THE BROKEN SCREW COULD NO

  Patient problems: Failure of Implant; Pain

  MAUDE report 10075301 ↗
• InjuryMay 17, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L4/5, L5/S1 DUE TO STENOSIS. THREE MONTHS POST-OP, THE IMPLANTED SCREW WAS BROKEN. AS A RESULT OF THIS EVENT PATIENT UNDERWENT REVISION SURGERY. THE PATIENT WENT TO ANOTHER HOSPITAL FOR REMOVAL OF THE SCREW, WHERE SCREW WAS REPLACED WITH ANOTHER MANUFACTURER SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10064044 ↗
• MalfunctionOct 9, 2018Break; Break

  IT WAS REPORTED THAT INTRA-OP, A SCREW BROKE. IT WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7946172 ↗
• MalfunctionOct 9, 2018Break; Break

  IT WAS REPORTED THAT INTRA-OP, A SCREW BROKE. IT WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7946169 ↗