CD HORIZON® SOLERA® Spinal System 651000040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169748521), received between Sep 22, 2026 and Sep 22, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 16, 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.

• InjurySep 22, 2026Use of Device Problem

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Open surgery Spinal therapy for degenerative spine condition. It was reported that during the procedure, difficult rod placement was encountered. The loaner set intended for the Voyager 4.75 mm system had been replenished with Voyager 5.5 mm implants, and wrong-diameter rods were placed. The surgeon was unable to lock the system with the locking nuts. The planned minimally invasive surgery was converted to open surgery, and the wound was opened on one side to remove the incorrect rods. The incorrect rods were explanted and replaced. Surgical time was extended by approximately 1 hour. There were unknown patient symptoms or complications reported. Additional information received from the manufacturer representative that there was no patient symptoms reported. Additional information received from the manufacturer representative that the levels involved was L5-S1. The quantity of the reported products were 2 minimal invasive rods 5.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850147 ↗
• InjurySep 22, 2026Use of Device Problem

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Open surgery Sp inal therapy for degenerative spine condition. It was reported that during the procedure,difficult rod placement was encountered. The loaner set intended for the Voyager 4.75 mm system had been replenished with Voyager 5.5 mm implants, and wrong-diameter rods were placed. The surgeon was unable to lock the system with the locking nuts. The planned minimally invasive surgery was converted to open surgery, and the wound was opened on one side to remove the incorrect rods. The incorrect rods were explanted and replaced. Surgical time was extended by approximately 1 hour. There were unknown patient symptoms or complications reported. Additional information received from the manufacturer representative that there was no patient symptoms reported. Additional information received from the manufacturer representative that the levels involved was L5-S1. The quantity of the reported products were 2 minimal invasive rods 5.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850145 ↗