CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850017540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169768345), received between Apr 3, 2025 and Apr 24, 2025 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, OTHER) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A LUMBAR FUSION PROCEDURE, A REDUCTION SCREW WAS INSERTED INTO THE SPINE'S VERTEBRAL BODY. THE SCREW IS EQUIPPED WITH A CLIP THAT IS INTENDED TO BE REMOVED ONCE THE SCREW IS SECURELY POSITIONED. HOWEVER, ONE OUT OF THE FOUR SCREWS USED HAD A CLIP THAT FAILED TO DETACH, RESULTING IN IT BEING RETAINED IN THE PATIENT AND CAUSING CONTINUED PAIN. THIS ISSUE WAS IDENTIFIED DURING A ROUTINE OFFICE VISIT ONE MONTH POST-OPERATION THROUGH AN X-RAY ON (B)(6) 2025. THE PATIENT IS SCHEDULED TO RETURN TO THE OPERATING ROOM TO HAVE THE CLIP REMOVED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 21898144 ↗
• InjuryApr 3, 2025Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE STATING, PATIENT REPORTED BACK PAIN, BUT SURGEON DID NOT ATTRIBUTE IT TO RETAINED TAB. TAB WAS IDENTIFIED AT POST OP FOLLOW UP ROUGHLY 4 WEEKS POST OP DURING ROUTINE X-RAY. REVISION SURGERY WAS PERFORMED WITHOUT INCIDENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760068 ↗