CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750045545Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169748927), received between Aug 22, 2024 and Aug 22, 2024 — classified as 1 malfunction.

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

• MalfunctionAug 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN P OSTERIOR SPINAL FIXATION FOR THORACIC HERNIA. LEVELS IMPLANTED WAS T6-T10. IT WAS REPORTED THAT DURING THE SURGERY, THE NAVIGATION ANTENNA MOVED SLIGHTLY AND WAS RE-TIGHTENED, BUT THE SCREW INSERTION WAS RESUMED AFTER IT WAS DETERMINED THAT THERE WAS NO SIGNIFICANT MISALIGNMENT ON THE IMAGES. AFTER INSERTION, 3D IMAGING WAS TAKEN BY O-ARM, AND SEVERAL PIECES WERE FOUND TO HAVE DEVIATED FROM THE PEDICLES, SO REINSERTION WAS PERFORMED AND THE FINAL TIGHTENING WAS PERFORMED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20029994 ↗