CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750017535Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169783898), received between May 11, 2020 and Mar 27, 2024 — classified as 2 injuries, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAD OLIF (L2/3/4) AND T10~SAI FIXATION AND L5/SPLIF FROM THE REAR. IT WAS REPORTED THAT THE LOOSE SCREW CAUSED INFECTION IN PATIENT. ALTHOUGH FIXATION WAS PERFORMED FROM T10 TO SAI, A WOUND APPEARED ON THE SKIN OF THE RIGHT SAI AREA AND PUS ALSO CAME OUT. WHEN IT WAS DEPLOYED, THE TISSUE FROM THE SKIN SURFACE TO THE SCREW HEAD CONTINUED TO HAVE DARK GRANULATION, AND THERE WAS PUS IN THE SURROUNDING AREA. THE SET SCREW IN THE SCREW HEAD WAS LOOSE ENOUGH THAT IT COULD BE REMOVED WITH FORCEPS, AND THE SURROUNDING TISSUE SHOWED DARK SPOTS AND BLACK POWDERY MATTER. THE SCREW THAT HAD BEEN INSERTED HAD A CLEAR ZONE ON THE IMAGE, BUT IT WAS REASONABLY EFFECTIVE. THE RIGHT SIDE WAS IN A NOTICEABLE CONDITION, BUT WHEN CHECKED THE LEFT SIDE, IT WAS IN THE SAME CONDITION. A REVISION SURGERY WAS PERFORMED DUE TO SUSPICION OF METALLOSIS DUE TO WEAR PARTICLES OF THE IMPLANT, BLACK GRANULATION ON THE SOFT TISSUES, WOUNDS ON THE WOUND SURFACE AND PUS IN THE VICINITY. IMPLANT WAS CUT AND REMOVED. INITIAL SURGERY WAS DONE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED. THE SET SCREWS WERE L

  Patient problems: Foreign Body Reaction; Post Operative Wound Infection

  MAUDE report 18984846 ↗
• InjurySep 28, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L5/S1 TLIF. IT WAS REPORTED THAT THE PATIENT UNDERWENT TLIF ON (B)(6) 2023 AT L5/S1, AND THE CY CAGE CONTRACTED IN AUGUST CAUSING THE GRAFTED BONE TO COMPRESS THE NERVE. THE GRAFTED BONE WAS COMING OUT LIKE A HERNIA AND PRESSING ON THE NERVE, SO THE CAGE WAS REMOVED AND REPLACED WITH MILESTONE IN AN ADDITIONAL SURGERY PERFORMED ON (B)(6) 2023. THE SCREWS WERE LOOSE AND THE PROCEDURE WAS COMPLETED BY REPLACING THE LOOSE SCREWS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Hernia; Undesired Nerve Stimulation

  MAUDE report 17832032 ↗
• MalfunctionMay 11, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCREW REMOVAL SURGERY AT L5/S DUE TO SPINAL CANAL STENOSIS. INTRA-OP, AT THE TIME OF REMOVING THE LEFT S1 SCREW, BREAKAGE WAS CONFIRMED AT THE SCREW HEAD AND SCREW SHAFT BY THE SAGITTAL IMAGE IN THE PROCESS OF INSERTING REMOVAL DRIVER INTO THE SCREW HEAD. ALTHOUGH THE SCREW DID NOT APPEAR TO BE BROKEN ON THE IMAGE. FRAGMENTS OF IMPLANT ARE REMAINING IN THE PATIENT. THE SURGEON DECIDED THAT THE FRAGMENT OF THE IMPLANT COULD NOT BE REMOVED, AND WOUND CLOSURE WAS PERFORMED. EXPLANATION WAS PERFORMED TO THE PATIENT, AND THE BROKEN PART WILL BE REMOVED ON ANOTHER DAY IF REQUESTED. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME AND NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10041786 ↗