CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850017545Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169768352), received between Mar 28, 2020 and Feb 26, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE FINAL TIGHTENING FAILED EVEN AFTER TRYING WITH MULTIPLE SET SCREWS, AND EVEN WITH ADEQUATE REDUCTION. SET SCREWS WON'T BREAK OFF, EVEN THOUGH THAT "SNAPPING" SOUND WAS PRESENT. FINAL TIGHTENING WAS ACHIEVED WITH NO ISSUE, AFTER THE SCREW HAD BEEN REPLACED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WERE 6 VOYAGER SET SCREWS THAT WERE USED DURING THE PROCEDURE, AND INADVERTENTLY GOT DAMAGED AFTER ALL OF THEM WERE USED TO LOCK IN A ROD IN THAT SAME PEDICLE SCREW TULIP. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE THERAPY WAS L4-S1 TRANSFORAMINAL INTERBODY FUSION AND THE PRE-OPERATIVE DIAGNOSIS WAS L5/S1 SPONDYLOLISTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466800 ↗
• MalfunctionOct 21, 2024Material Deformation; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490984 ↗
• InjuryMar 10, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH SCREWS IN AN L4-S1 CONSTRUCT EXTENDED TO L3-PELVIS. IT WAS REPORTED THAT THE SCREWS BROKE AT THE PROXIMAL END OF SHAFT, APPROXIMATELY 1CM FROM HEAD. THE SHAFT OF THE SCREWS WERE LEFT IMPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S MEDICAL HISTORY INCLUDES SPINAL STENOSIS, PRIOR FUSION. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520006 ↗
• InjuryMar 10, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH SCREWS IN AN L4-S1 CONSTRUCT EXTENDED TO L3-PELVIS. IT WAS REPORTED THAT THE SCREWS BROKE AT THE PROXIMAL END OF SHAFT, APPROXIMATELY 1CM FROM HEAD. THE SHAFT OF THE SCREWS WERE LEFT I MPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S MEDICAL HISTORY INCLUDES SPINAL STENOSIS, PRIOR FUSION. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520003 ↗
• InjuryMar 28, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  PRE OP DIAGNOSIS: LOOSE SET SCREWS PROCEDURE PERFORMED: REVISION SURGERY TO REPLACE LOOSE SET SCREWS POST-OP, SCREWS BACK OUT. REVISION SURGERY UNDERTAKEN TO REPLACE RIGHT L5 MIGRATED SCREW. THE PATIENT SUFFERED PAIN AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 9892528 ↗