CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750018545Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169783973), received between Jul 19, 2021 and Oct 12, 2021 — classified as 1 injury, 1 malfunction.

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

• MalfunctionOct 12, 2021Material Deformation; Material Deformation

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH ADJACENT SEGMENT DISEASE AT L2-5 FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREW DID NOT FIT IN THE L3 LEFT SCREW, THE TAB WAS BROKEN OFF, AND THE THREAD ON THE SCREW HEAD SIDE WAS SHAVED, SO THEY REPLACED THE SCREW. THE SET SCREW HAD A DAMAGED THREAD, AND THE TIP WAS DEFORMED AND SCRATCHED. THE SCREW TABS BROKEN, SCRATCHED ON THE EDGES AND BOTTOM OF THE SCREW NECK / CROWN / TORX HOLES, AND THE SCREW HEAD THREADS. AN ATTEMPT WAS MADE TO INSERT THE SET SCREW INTO THE REPORTED SCREW, BUT IT COULD NOT BE SET. THERE WAS LESS THAN 60 MIN DELAY IN OVERALL PROCEDURE TIME. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12613136 ↗
• 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 12187112 ↗