CD HORIZON® Spinal System 8115534Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00721902729638), received between Jan 27, 2020 and Dec 12, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL DEFORMITY CORRECTION PROCEDURE SCOLIOSIS CORRECTION CASE FROM T7-L4 DOUBLE CURVE WITH CROSSLINK USED AFTER THE ROD PLACEMENT. LEVELS IMPLANTED WAS T7-L4. IT WAS REPORTED THAT DURING A SCOLIOSIS CORRECTION PROCEDURE, THE TIP OF CROSSLINK WAS BROKEN DURING FINAL TIGHTENING AND NO FRAGMENT REMAINED IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786805 ↗
• MalfunctionDec 6, 2021Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR IDIOPATHIC SCOLIOSIS. IT WAS REPORTED THAT SCREW CAP WAS NOT TIGHT AFTER DETACHING, SO IT WAS DISASSEMBLED. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12932149 ↗
• MalfunctionJan 27, 2020Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH T5-T7 VERTEBRAL FRACTURE AND DISLOCATION WITH PARAPLEGIA. HE UNDERWENT POSTERIOR T5-T7 FRACTURE AND DISLOCATION OPEN REDUCTION, VERTEBRAL CANAL DECOMPRESSION, VERTEBRAL BODY RESECTION, BONE GRAFT FUSION AND PEDICLE SCREW INTERNAL FIXATION. INTRA-OP, THE SCREW PLUG OF CROSSLINK SLIPPED, AND COULD NOT BE FIXED. HENCE, THE PRODUCT WAS COMPLETELY EXPLANTED AND WAS REPLACED BY ANOTHER PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9633648 ↗