CD HORIZON® Spinal System 1606200500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169319462), received between Sep 28, 2018 and Mar 3, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 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.

• InjuryMar 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA DISTRIBUTOR REGARDING A PATIENT UNDERWENT SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS ADOLESCENT IDIOPATHIC SCOLIOSIS. IT WAS REPORTED THAT, PATIENT HAD SOME MILD INCREASE IN PAIN NEARLY FOR 4 MONTHS AFTER THE SURGERY. SET CAPS DID NOT HOLD THE RODS AS NEEDED. THE ROD CAME OUT OF THE SET CAP AND SCREWHEAD AFTER THE SURGERY. X-RAY PERFORMED ON (B)(6)2025 SHOWS RODS NO LONGER HELD BY ORIGINAL CONSTRUCT AT L3. THE LEVELS IMPLANTED WERE T3-L3. PROCEDURE/TECHNIQUE PERFORMED DURING INITIAL SURGERY WAS ADOLESCENT IDIOPATHIC SCOLIOSIS SURGERY. PATIENT UNDERWENT REVISION SURGERY, AND THE REPORTED PRODUCTS WERE EXPLANTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 21502065 ↗
• InjuryJul 18, 2022Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T4-T9 LUMBAR RE VISION FOR MULTIPLE FRACTURED RODS. THE PATIENT HAD INITIAL SURGERY OF T2-PELVIS THORACOLUMBAR FUSION. IT WAS REPORTED THAT THE COBALT CHROME TAPERED APEX RODS WERE FRACTURED AND ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2022 TO REMOVE THE RODS AND SOME OF THE ASSOCIATED CONNECTORS AND REPLACED WITH NEW RODS AND CONNECTORS TO UPHOLD THE CONSTRUCT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15049034 ↗
• InjurySep 28, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PEDIATRIC SCOLIOSIS DEFORMITY CORRECTION SURGERY. POST-OP, THE ROD CAME COMPLETELY OUT OF THE CLOSED HEAD TULIP. NO FUSION COULD BE ACHIEVED DUE TO THIS EVENT. HENCE, ON (B)(6)2018, THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE ROD WAS REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 7917624 ↗