CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850015545Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169768192), received between Jul 5, 2022 and Jun 18, 2025 — 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.

• InjuryJun 18, 2025Difficult to Remove; Mechanics Altered; Device Handling Problem; Difficult to Remove; Mechanics Altered; Device Handling Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A REDUCTION SCREW USED FOR LUMBAR FUSION. IT WAS REPORTED THAT DURING PATIENT'S ONE MONTH POST OP VISIT DISCOVERED THAT THE CLIP ON THE REDUCTION SCREW FAILED TO REMOVE AND WAS UNINTENTIONALLY LEFT BEHIND. THE CLIP WAS INSERTED INTO SPINE VERTEBRAL BODY TO COMPLETE A LUMBAR FUSION WAS DESIGNED TO BE REMOVED ONCE THE SCREW IS SET INTO POSITION. PATIENT STILL HAVING COMPLICATIONS LIKE R/T NUMBNESS AND WEAKNESS, ALSO HAD SUFFERED 7 FALLS AT HOME LEADING UP TO THE DISCOVERY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Foreign Body In Patient; Muscle Weakness/Atrophy; Numbness

  MAUDE report 22278412 ↗
• MalfunctionFeb 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN SPINAL THERAPY. COMPRESSION FRACTURE AT L3. SCREWS AT L2, L4. IT WAS REPORTED THAT THE SCREW BROKE IN L4. 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 21444437 ↗
• InjuryJul 5, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH SCREWS IN A PERCUTANEOUS PSF AT T10-L2. IT WAS REPORTED THAT THE SCREWS MALFUNCTIONED SOMETIME BETWEEN IMPLANT AND REMOVAL, LIKELY DURING ONE OF THE PATIENT'S FALLS. UPON EXPLANTATION, THE HCP NOTICED THAT THE SCREWS TULIPS WERE WELDED TO THE SHANK IN A WAY THAT THE POLY AXIAL RANGE OF MOTION WAS LOST AND THE TULIP WAS ¿FIXATED¿ AT A DIFFERENT DEGREE FOR EACH OF THE RESPECTIVE SCREWS. THE SURGEON WAS UNABLE TO PUT THE SHANK OF THE DRIVER THROUGH THE TULIP TO SEAT IT INSIDE OF THE SCREW SHANK BECAUSE THE FIXATED TULIP WAS BLOCKING A STRAIGHT PATH WAY FOR THE DRIVER TO SEAT. THE MALFUNCTIONING OF THE SCREWS WAS LIKELY DUE TO A FALL. THE PATIENT IS OSTEOPOROTIC AND THE SCREWS WERE HALOING SEVERELY AND LOOSE. THE PATIENT HAS HAD MULTIPLE FALLS. THE HCP DETERMINED THAT THE SCREWS DID NOT STABILIZE THE PATIENT AS HE HAD HOPED. THE SURGEON DECIDED TO REMOVE HARDWARE AS PART OF HER PREVENTATIVE TREATMENT PLAN AND AT THE TIME OF THE HARDWARE REMOVAL, HE NOTICED THE SCREW MALFUNCTION. THERE IS NO INJURY TO THE PATIENT DUE TO THE SCREW MALFUNCTION. THE DATE OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14913654 ↗