CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750018540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169783966), received between Jul 19, 2021 and Jan 29, 2025 — classified as 1 injury, 1 malfunction.

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

• MalfunctionJan 29, 2025Break; Break

  (B)(6) 2023 MPXR (B)(6) (REP, HCP, FOR): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR VERTEBRAL FUSION FOR ADJACENT INTERVERTEBRAL DISORDER. LEVEL AT WHICH THE IMPLANT WAS PERFORMED: L3-S2 IT WAS REPORTED THAT WHEN INSERTING THE LEFT L4 SCREW, A LOAD WAS APPLIED TO THE TIP OF THE SCREWDRIVER, RESULTING IN BREAKAGE. THE BROKEN PART OF THE SCREWDRIVER TIP WAS CONFIRMED INSIDE THE SCREW HEAD. THE SCREW WAS REMOVED ONCE AND REPLACED WITH A NEW SCREW OF THE SAME SIZE. DATE OF INITIAL SURGERY: (B)(6) 2010, LEVEL AT WHICH IMPLANT WAS PERFORMED: L4/5, NO PRODUCT MALFUNCTION WAS REPORTED AGAINST THE PRODUCT USED IN THE INITIAL SURGERY. THE REPORTED SCREW WAS FRACTURED. THERE WAS A DELAY IN THE PROCEDURE BY LESS THAN 60 MINS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263585 ↗
• InjuryJul 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH L4 / 5 / S SPINAL CANAL STENOSIS FOR OLIF OF L4 / 5 / S AND POSTERIOR L4 / 5 / S FIXATION SPINAL THERAPY. IT WAS REPORTED THAT THE L5 / S SCREWS AND THE POSTERIOR SCREWS WERE LOOSENED DUE TO INFECTION, THE ANTERIOR CAGE, SCREWS AND POSTERIOR SCREWS WERE REMOVED, AND THE ILIUM WAS COLLECTED, AND ANTERIOR FIXATION WAS PERFORMED. AFTER THAT, POSTERIOR L4 / 5 / S / S2 FIXATION WAS PERFORMED. THERE WAS NO FURTHER INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 12187109 ↗