CD HORIZON® Spinal System 25840019580Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169413221), received between Feb 19, 2025 and Apr 18, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A POSTERIOR THORACOLUMBAR FUSION IN A PATIENT. IT WAS REPORTED THAT THE SET SCREW BACKED OFF THE TULIP. A LAMINECTOMY WAS ALSO PERFORMED IN THE THORACIC REGION WHEN THE ILLIAC SCREWS WERE REPLACED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21863172 ↗
• MalfunctionFeb 19, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE SCREWS WERE COLD WELDED/STRIPPED DUE TO DRIVER MALFUNCTION INTRAOPERATIVELY. HAD TO HELICOPTER OUT AFTER NUMEROUS ATTEMPTS TO REMOVE USING A MULTITUDE OF DRIVERS. ONE OF THE DRIVERS WAS SEVERELY WARPED AFTER ATTEMPTING TO PLACE 10.5 SCREW. WHEN ATTEMPTING TO PLACE SECOND SCREW (10.5X80) THE TORX TIP OF THE DRIVER SNAPPED OFF AND LODGED INSIDE THE TULIP/TORX INTERFACE OF THE SCREW. FRAGMENTS COULD NOT BE REMOVED AND IT WAS LEFT IN THE PT. THE OTHER DRIVER WAS SEVERELY WARPED AFTER ATTEMPTING TO PLACE 9.5 SCREW. SURGEON WAS FEARFUL OF SNAPPING OFF TIP OF THE DRIVER AGAIN SO THE DECISION WAS MADE TO HELICOPTER THE SCREW OUT AND LEAVE UNILATERAL PELVIC FIXATION. PRODUCTS WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS PSF L2-PELVIS WITH TLIF L3-5. PRE-OP DIAGNOSIS M43.16/M54.16/M40.30/M47.26. BOTH BALLAST DRIVERS WERE SEVERELY WARPED AND STRIPPED. THE PRODUCT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417821 ↗