CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750047540Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169749092), received between Nov 14, 2022 and Nov 14, 2022 — classified as 1 injury.

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

• InjuryNov 14, 2022Use of Device Problem; Migration; Use of Device Problem; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT USED IN OBLIQUE LUMBAR INTERBODY FUSION (OLIF) SPINAL THERAPY FOR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT AFTER THE PROCEDURE THE SCREWS WERE DEVIATED. THERE IS A POSSIBILITY OF L5 ROOT SYMPTOMS AFTER SURGERY AND PROLONGED HOSPITALIZATION TO FIX AGAIN THROUGH REVISION SURGERY. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT ALL THE REPORTED SCREWS WERE DEVIATED AFTER INITIAL SURGERY AND WERE EXPLANTED IN THE REVISION SURGERY. THE LOT NUMBERS OF THE REPORTED PRODUCTS ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT AS A RESULT OF THE VERIFICATION, IT BECAME CLEAR THAT IT WAS A HUMAN ERROR. IN A LATERAL DECUBITUS POSITION, A CAGE WAS INSERTED USING THE OLIF AT THIS HOSPITAL, AND THEN THE PERCUTANEOUS PEDICLE SCREW (PPS) WAS PERFORMED AS IS IN A LATERAL DECUBITUS POSITION. UPON NAVIGATION AFTER THE CAGE INSERTION, THE VERTEBRAL BODY MOVES DUE TO THE CAGE, SO THE O-ARM IMAGING WAS PERFORMED AGAIN NAVIGATION WAS USED; ACCIDENTALLY SELECTED THE O-

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 15786838 ↗