CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750046540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169749009), received between Nov 14, 2022 and Jan 9, 2026 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026No Apparent Adverse Event

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION SURGERY. IT WAS REPORTED THAT, REVISION SURGERY WAS PERFORMED DUE TO NON-FUSION AT L5/S. DURING THE REVISION, CAGE WAS REMOVED AND REPLACED WITH A NEW ONE AND FIXATED THE EXTENSION TO THE L4 - S2AI. THE SET SCREW WAS REMOVED, AND WHEN DISTRACTION WAS APPLIED BETWEEN THE SCREW BEFORE IT WAS REMOVED, THE SET SCREW WHICH WAS ATTACHED TO THE 7.5 X 40 SCREW HEAD ON BOTH SIDES WHERE THE SCREW HEAD MOVES, WAS NOT COMPLETELY LOCKED EVEN THOUGH IT WAS PROPERLY SCREWED. INITIAL SURGERY WAS PERFORMED ON (B)(6) 2025, L5/S TRANSFORAMINAL LUMBAR INTERBODY FUSION WAS PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017603 ↗
• MalfunctionJan 9, 2026No Apparent Adverse Event

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION SURGERY. IT WAS REPORTED THAT, REVISION SURGERY WAS PERFORMED DUE TO NON FUSION AT L5/S. DURING THE REVISION, CAGE WAS REMOVED AND REPLACED WITH A NEW ONE, AND FIXATED THE EXTENSION TO THE L4 - S2AI. THE SET SCREW WAS REMOVED, AND WHEN DISTRACTION WAS APPLIED BETWEEN THE SCREW BEFORE IT WAS REMOVED, THE SET SCREW WHICH WAS ATTACHED TO THE 7.5 X 40 SCREW HEAD ON BOTH SIDES WHERE THE SCREW HEAD MOVES, WAS NOT COMPLETELY LOCKED EVEN THOUGH IT WAS PROPERLY SCREWED. INITIAL SURGERY WAS PERFORMED ON (B)(6) 2025, L5/S TRANSFORAMINAL LUMBAR INTERBODY FUSION WAS PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017477 ↗
• InjuryNov 14, 2022Use of Device Problem; Migration; Use of Device Problem; Migration

  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-ARM IMAGING DATA BEFORE INSERTING THE CAGE ON THE NAVIGATION EVEN DURING PPS, AND THE SCREW WAS INSERTED UNNOTICED AS IS. THEREFORE, IT WAS DECIDED THAT EVEN THOUGH THE SCREW INSERTION WAS ACCURATE ON THE N

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 15786843 ↗