CD HORIZON® SOLERA® VOYAGER™ Spinal System 54850047545Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169787506), received between Mar 12, 2025 and Mar 12, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionMar 12, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED IN ROBOTIC GUIDED PEDICLE SCREW PLACEMENT LUMBAR 5 THERAPY FOR STENOSIS. IT WAS REPORTED THAT THE PATIENT WAS FINE BUT WHEN THE SURGEON TRIED SNAPPING OFF THE VOYAGER 4.75 PERC SET SCREW IT WOULDN¿T BREAK OFF. THE HANDLE WOULD ¿SKIP¿ AND NOT BREAK OFF. IT IS THOUGHT THAT THE SCREW MAYBE DEFECTIVE AND MAYBE THE SETSCREW SPLAYED THE HEAD OF THE SCREW. IT APPEARED TO BE SLIGHTLY SPLAYED. ABOUT 3 DIFFERENT SETSCREWS WERE TRIED AND THEN A LONGER ROD. IT WAS ALSO TRIED TO RAISE L4 TO MAKE L4 AND 5 NEARLY IDENTICAL IN HEIGHT. THEY HAD TRIED BACKING THAT SCREW OFF A BIT EVEN THOUGH SCREW WAS NOT BURIED IN BONE, IT HAD FULL RANGE OF MOTION. FINALLY THEY REPLACED THE SCREW WITH ANTHER 7.5X45 AND IT WORKED. NO ADDITIONAL SURGERY WAS PERFORMED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WERE NO OTHER PRODUCT MALFUNCTIONS IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21581043 ↗