CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750014540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169783720), received between Jan 26, 2025 and Jun 10, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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.

• InjuryJun 10, 2026Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE VERTEBRAL BODIES AROUND T12 AND L1 ARE DETERIORATING. AS A RESULT, THE L1 SCREWS HAVE BACKED OUT, AND THE RODS WERE PROTRUDING. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO NEED FOR HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION, REVISION SURGERY WAS PERFORMED ON (B)(6) 2026. THE DEVICES WERE EXPLANTED AND RETURNED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25458483 ↗
• InjuryJun 10, 2026Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE VERTEBRAL BODIES AROUND T12 AND L1 ARE DETERIORATING. AS A RESULT, THE L1 SCREWS HAVE BACKED OUT, AND THE RODS WERE PROTRUDING. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO NEED FOR HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION, REVISION SURGERY WAS DONE ON (B)(6). THE DEVICES WERE EXPLANTED AND RETURNED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25458361 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING SCREWS USED IN PLIF FOR L4/5 LCS. IT WAS REPORTED THAT WHEN THE ROD WAS INSERTED, THE ROD INTERFERED WITH THE EXTENDER TAB OF THE SCREW, CAUSING THE EXTENDER TAB TO BREAK. THE BROKEN SCREW WAS REMOVED, AND A NEW SCREW WAS INSERTED. THERE WAS A DELAY OF LESS THAN 60 MINS. SCREW CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21237223 ↗