CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750015530Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169783744), received between Jun 18, 2025 and Jun 18, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanics Altered” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY COMBINED WITH PERCUTANEOUS PEDICLE SCREW (PPS) THERAPY FOR OSTEOPOROTIC VERTEBRAL FRACTURE (OVF). IT WAS REPORTED THAT DURING THE PROCEDURE, AN ISSUE OCCURRED WHERE THE DRIVER COULD NOT FIT WITH SCREW. A NEW DRIVER OF THE SAME SIZE WAS OPENED. UPON CHECKING AFTER THE PROCEDURE, IT FIT CORRECTLY. SCREW WAS NEVER IMPLANTED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AND THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE SCREW WAS NOT FIT PROPERLY WHEN IT WAS ATTACHED TO THE DRIVER OUTSIDE THE SURGICAL FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282255 ↗